The Project On Government Oversight (POGO) Blog

FOIA Friday: 21 Previously Unreleased FDA Inspection Reports

FOIA FRIDAY

This week's document: Internal emails from the Department of Energy's Energy Information Administration responding to a New York Times article on fraking.  Document dates: June and July, 2011 Every Friday, POGO will strive to make one document available that we or others have obtained through the Freedom of Information Act (FOIA), especially documents that have not previously been posted online. Some of these documents will be more important than others, some may only be of historical interest— although relevance is in the eye of the beholder. POGO is doing this to highlight the importance of open government and FOIA throughout the year.

By DANA LIEBELSON and BRYAN RAHIJA

As part of our Sunshine Week coverage last month, POGO released a Food and Drug Administration (FDA) inspection report outlining problems the agency discovered at Invacare, a company that makes medical beds. But that inspection report was just one of a handful that POGO obtained through a Freedom of Information Act (FOIA) request. Today, we’re releasing those other reports. 

These inspection reports give the public insight into the companies and products the agency inspected. While the FDA has created a database that gives the public access to cursory information on these reports, the FDA should consider proactively making the reports themselves publicly available.

Here are snippets from five reports that caught our eye, plus a list of the other inspection reports we obtained. 

Inspection of Marina Medical Instruments (maker of forceps and retractors)

Date of inspection: 12/3/2008-12/5/2008

Notable FDA Observation: “Adequate quality requirements that must be met by suppliers and contractors were not established, defined, documented, and implemented.”

Excerpt: “In a follow-up to complaint in March 2007 regarding rupture of cuff of Uterine Manipulator inside a patient’s uterus, there was no investigation documented by Marina Medical.”

Inspection of American Catheter Corp (maker of catheters)

Date of inspection: 6/10/2009-6/17/2009

Notable FDA Observation: “[Company] did not implement the procedure covering the sterilization process for the 9100 Series and 9100L Series Cholangiogram Catheters.”

Excerpt: “I randomly selected 20 continuous temperature records and found 9 of 20 continuous temperature records covering the [Redacted] portion of the sterilization process had deficiencies.”

Inspection of Munroe Regional Medical Centre (maker of EsophyX device) 

Date of inspection: 9/14/2009-9/21/2009

Notable FDA Observation: “Written Medical Device Reporting (MDR) procedure did not include an internal system which provides for the timely and effective identification and evaluation of events.”

Excerpt: “A patient [suffered] a torn esophagus during a procedure utilizing the EsophyX device…your Director of Materials Management determined the event was not reportable injury…although CT scans performed at your facility showed fluid leaking into the chest cavity.”

Inspection of Suncoast Laboratories (maker of hearing aids)

Date of inspection: 11/17/2008-12/1/2008

Notable FDA Observation: “Lacked management control procedures [with hearing aid devices].”

Excerpt: “I asked Mr. Haddad to show me the firm’s training records. He promised to provide the records next day. Throughout the inspection, he was unable to show employee training records. Later, he admitted he did not have any.”

Inspection of Healthline Medical Products, Inc (maker of shower commode chairs) 

Date of inspection: 11/3/2008-11/7/2008

Notable FDA Observation: “[The company] failed to implement a corrective action regarding a complaint showing the failure of the Shower Commode Chair… assembly guide found to be inadequate.”

Excerpt: “Healthline investigation failed to determine the possible root-cause of [a] cracked seat…connector failure…and loose joint.”

Other FDA inspection reports POGO obtained through FOIA (listed in order of inspection end date)

• Inspection of IVD Research Inc, maker of in-vitro diagnostic devices, 10/09/08
• Inspection of Amrex Zetron Inc, maker of electrotherapy equipment, 11/03/08
• Inspection of  Stat Medical Devices, Inc., maker of lancing devices, 12/05/08
• Inspection of Therasage LLC, maker of heating pads, 1/13/09
• Inspection of Electro-Tech Products Inc, maker of transcutaneous electrical nerve stimulators, 2/17/09
• Inspection of ARJ Medical, Inc., specification developer of urinalysis reagent strips, 3/09/10
• Inspection of Linvatec Corp. dba ConMed Linvatec, maker of surgical instruments, 3/26/09
• Inspection of  Neo Imagery Technologies, Inc, maker of diagnostic imaging workstations, 5/01/09
• Inspection of Alphatec Spine, Inc, maker of spinal implants, 5/18/09
• Inspection of  Clearwater Products, LLC, maker of colonic irrigation system, 8/25/09
• Inspection of  Magnificent Medical Equipment, Inc. DBA Tony Riso Company, 11/19/09
• Inspection of  Hyperbaric America LLC, maker of hyperbaric systems, 12/02/09
• Inspection of DexCom, Inc, maker of the Seven Continuous Glucose Monitoring System, 2/08/10
• Inspection of Care Tech Industries, Inc., maker of recirculating air cleaners, 06/10/10
• Inspection of Zander Scientific Inc. DBA Zander, maker of air purification system, 7/14/10
• Inspection of Toby’s Nose Filters, Inc., maker of nose filters, 9/23/10

 

Dana Liebelson is POGO's Beth Daley Impact Fellow. Bryan Rahija edits POGO's blog.

Follow @dliebelson

Follow @bryanrahija

New FOIA Portal Gets High Marks

By ANDREW WYNER

A House Oversight and Government Reform subcommittee belatedly celebrated Sunshine Week this past Wednesday by hosting a hearing on FOIA in the 21st century (the House was out of session during Sunshine Week itself). The witnesses, selected both from good government organizations and federal agencies, all testified before the Subcommittee on Technology, Information Policy, Intergovernmental Relations and Procurement Reform  on the importance of online Freedom of Information Act (FOIA) services. Witnesses were not, however, in complete agreement in exactly how to bring FOIA into the 21st century.

The FOIA Portal, being developed by the Environmental Protection Agency (EPA), the National Archives (NARA), and the Department of Commerce, received high marks from Members of Congress and witnesses alike. Acting Subcommittee Chairman Mike Kelly (D-PA) and Ranking Member Gerry Connolly (D-VA) were both enthused by the FOIA Portal and the positive impact it would have. Sean Moulton, director of Federal Information Policy at OMB Watch, stated  “Congress should make it clear it’s best for every agency to participate.” Moulton said that the problem with FOIA is “a lack of consistency. The FOIA portal offers a level of consistency across government.”

Senate Judiciary Committee Talks FOIA and the Public's Right to Know

By SUZANNE DERSHOWITZ

Held during Sunshine Week, last Tuesday's Senate Judiciary Committee hearing, "The Freedom of Information Act: Safeguarding Critical Infrastructure Information and the Public’s Right to Know," was timely indeed. A wide range of issues were discussed, from the multi-agency FOIA portal scheduled to launch October 1 to the cybersecurity legislation pending in both the Senate and the House. The broad scope of topics covered perhaps illustrated the need for more hearings about FOIA and open government issues.

Chairman Patrick Leahy (D-VT), a longtime champion of FOIA and open government, said that “excessive government secrecy can come at an unacceptable price.” Last year, POGO and partners urged Congress to fix the over-broad and ill-defined provision relating to critical infrastructure information (CII) that the Department of Defense (DoD) was seeking in the National Defense Authorization Act (NDAA) for 2012. Sen. Leahy and Rep. Carolyn Maloney (D-NY) were successful in narrowing the blanket exemption to FOIA for CII. Their amendment requires DoD not to use FOIA’s CII exemption in cases where the public interest outweighs national security concerns. Jerry Ensminger’s testimony about the latest developments in the cover-up at Camp Lejeune demonstrated that more work needs to be done to ensure implementation of the law.

Witnesses on the first panel included Miriam Nisbet, director of the Office of Government Information Services (OGIS) and Melanie Pustay, Director of Information Policy (OIP) at the Department of Justice (DOJ). In addition to managing DOJ’s FOIA administration, OIP is responsible for encouraging and overseeing agency compliance with FOIA and for ensuring that the President’s FOIA Memorandum is fully implemented across the government. 

Sen. Grassley (R-IA) said that the President’s promise to build the most transparent administration in history has not translated into meaningful open government reform. Sen. Grassley pointed to the DOJ winning the Rosemary Award for worst open government performance in 2011.

Sens. Grassley and Leahy were clearly exasperated that Congress hadn’t received OGIS’s recommendations for improving agency compliance with FOIA. Nisbet said OGIS submitted recommendations to the Office of Management and Budget (OMB) for review over a year ago. "We haven’t received them yet,” said Leahy. “The law requires us to receive them. When will we receive them?"  He then offered to drive over to OMB to pick the recommendations up himself. When pressed, Nisbet promised to get “something” to Congress within a month.

SUNSHINE WEEK: Wonks, Journos, Former Feds Talk Government Secrecy

By BRYAN RAHIJA

Who needs college basketball when you could be debating government accountability? All eyes at POGO HQ this afternoon were fixed not on bracket-busting underdogs, but on a Sunshine Week panel moderated by POGO head honcho Danielle Brian on the balance between protecting national security and maintaining an open and accountable government.  

The all-star panel touched on over-classification of government records, congressional oversight, whistleblower protections, the proliferation of security clearances, and contractors' increasing role in core government activities.  

Jeffrey H. Smith, former general counsel of the CIA, said that the best solution for the current lack of congressional oversight is simply that Congress needs to use more of the powers it already has. 

Dana Priest, the Washington Post reporter behind the "Top Secret America" series and the book of the same name, pointed out that part of the reason for the massive expansion of the contracting community surrounding intelligence agencies was that Congress gave the agencies billions of dollars to ramp up their activities—but with an understanding that agencies wouldn't make the government any bigger.  

SUNSHINE WEEK: Many Agencies Violate FOIA's 20 Day Requirement

By ANDREW WYNER

The Freedom of Information Act (FOIA) is one of the most powerful tools to pry public information out of the federal government. But while FOIA requires agencies to respond to a request for information within 20 business days, an analysis of a recent batch of POGO FOIA requests shows that many agencies are violating the law by failing to meet even this basic requirement.

Between February 3 and 6—over 20 business days ago—POGO submitted 100 FOIA requests for work done by federally contracted consultants. POGO requested a specific written report or briefing produced by contractors hired as consultants to federal agencies as well as the respective statement of work—all from named contracts. POGO submitted the requests to 30 different agencies and departments.

To date, agencies have failed to acknowledge receipt of or respond to 23 of these requests. The following agencies have not sent an email or letter responding to POGO’s request: the Department of the Treasury; the IRS; the Bureau of Ocean Energy Management, Regulation, and Enforcement (BOEMRE); Defense Finance and Accounting Services (DFAS); and the Department of Justice (DOJ). Three FOIA offices—those of the Army, U.S. Agency for International Development (USAID), and the Department of Energy (DOE)—have acknowledged some but not all of the requests POGO sent to them.

POGO received only 8 final, conclusive responses to FOIA requests within 20 business days. But in five of those cases, the agencies told POGO that after a search there were no documents that could fulfill the request. POGO received two additional responses shortly after the 20-day mark.

The 20-day minimum requirement for acknowledgement under FOIA is a low bar, but in this case, it was a bar that agencies couldn’t clear in nearly one out of four requests.

This batch of requests also shed light on agencies’ use of extensions.

SUNSHINE WEEK: Thousands of Government Requests to Fix Contractor Deficiencies

By NICK SCHWELLENBACH

As part of Sunshine Week, a national initiative to highlight the importance of open government and freedom of information, POGO is releasing a host records obtained by the Freedom of Information Act (FOIA). Read more about POGO's plans for Sunshine Week here.

The Defense Contract Management Agency (DCMA) sent thousands of requests to hundreds of companies notifying them of problems that should be addressed between July 1, 2009, and July 31, 2011, according to a DCMA database obtained by POGO through the Freedom of Information Act (FOIA). The deficiencies cited by DCMA range from mundane to serious and are ranked accordingly as levels I, II, III, or IV, each one more serious than the last.

The database gives the public some insight into how the government is overseeing the quality of contractors’ work. It can highlight how aggressively the government is pursuing corrective actions and whether or not a contractor might have some problems.

Some basic info on the database

The DCMA database was a response to Government Accountability Office (GAO) criticism of DCMA for not having a centralized way of tracking its corrective action requests (CARs).

Each entry in the database should, in theory, represent an individual CAR. However, some appear to be duplicative, and DCMA has told POGO in response to follow-up requests related to some individual CARs that some are.

There are 21,620 entries in the database covering 2,299 suppliers (many suppliers are part of the same company). There are 11,909 Level I CARs, 9,606 Level IIs, 103 Level IIIs and 2 Level IVs over the slightly more than two-year period.

SUNSHINE WEEK: Revolving Regulators at the CFTC

By ANDREW WYNER and MICHAEL SMALLBERG

Click here to join POGO's Un-Do Influence Campaign: a movement to reclaim Washington

As part of Sunshine Week, a national initiative to highlight the importance of open government and freedom of information, POGO is releasing a host records obtained by the Freedom of Information Act (FOIA). Read more about POGO's plans for Sunshine Week here.

Since 2006, at least seven former employees of the Commodity Futures Trading Commission (CFTC) have disclosed their intent to appear before the CFTC on behalf of a client shortly after leaving the Commission, according to CFTC post-employment statements provided to POGO in response to a Freedom of Information Act (FOIA) request. Because the revolving door potentially engenders serious conflicts of interest, POGO believes that the CFTC and similar agencies should readily disclose post-employment records to the public.

Like other executive branch employees, CFTC staffers face certain restrictions on their post-employment activities. For instance, former employees can never appear in a representative capacity before the CFTC on a particular issue if they worked closely on that issue during their time at the Commission. In addition, according to federal statute, former CFTC commissioners and certain senior employees must wait a year before they attempt to influence the Commission on any issue.

SUNSHINE WEEK: Pentagon Drone Reports Show Big Budgets, Low Performance

By BEN FREEMAN

As part of Sunshine Week, a national initiative to highlight the importance of open government and freedom of information, POGO is releasing a host documents obtained by the Freedom of Information Act (FOIA). Read more about POGO's plans for Sunshine Week here. 

The Department of Defense (DoD) Office of the Under Secretary of Defense for Acquisition, Technology, and Logistics (AT&L) is responsible for providing Congress with Selected Acquisition Reports (SAR) for major weapons programs. By tracking cost and performance objectives, these SARs indicate whether taxpayers are getting bang for their buck. Most taxpayers never see SARs unfortunately, because they are not typically made available to the public. However, through a Freedom of Information Act (FOIA) request, POGO obtained SARs for the Reaper and Global Hawk drones, and is making those documents publicly available for the first time.

SUNSHINE WEEK: Nuke Regulator Initially Declined to Investigate Allegations of On-the-Job Inebriation, IG Docs Show

By MIA STEINLE

As part of Sunshine Week, a national initiative to highlight the importance of open government and freedom of information, POGO is releasing a host documents obtained by the Freedom of Information Act (FOIA). Read more about POGO's plans for Sunshine Week here. 

Tasked with holding accountable a federal agency or a military branch, an inspector general (IG) has one of the most important jobs in the U.S. government. However, with many IG investigations only accessible through Freedom of Information Act (FOIA) requests, much of an IG's work remains unseen, which means taxpayers are often unaware, both of these investigations and of the government wrongdoing they uncover. Through FOIA, we recently obtained IG documents about one such case: a troubling incident involving drunkenness on the job, a mismanaged investigation, and the U.S. agency that oversees nuclear power.

Nuclear Regulatory Commission (NRC) IG documents obtained by POGO outline a 2006 case in which the president of Nuclear Fuel Services (NFS)—a company that is licensed by the NRC to manufacture nuclear fuel for Navy submarines—allegedly “attended a force-on-force exercise under the influence of alcohol.” (A force-on-force exercise is a prescheduled security inspection conducted by the NRC to simulate threats to nuclear facilities.)

POGO to Participate in Sunshine Week Twitter Chat Today

By DANA LIEBELSON

This afternoon, POGO Executive Director Danielle Brian and other experts will be available to answer your questions on the Freedom of Information Act (FOIA) through Twitter. In celebration of Sunshine Week, the American Society of News Editors (@ASNEChat) is hosting the chat from 2 to 3 p.m. EDT.

FOIA is a great tool for the public to gain insight into government actions—but it can also be slow and confusing, even for FOIA experts. Want to know which federal agencies are least effective at grant requests in an efficient manner? Curious to learn more about the Obama Administration’s track record on open government? This is a great opportunity to get questions like these answered by good government groups.

Some of the participants are:  POGO Executive Director Danielle Brian(@daniellebrian), OpenTheGov.org Executive Director Patrice McDermott (@OpenTheGov), Reporters Committee for Freedom of the Press Executive Director Lucy Dalglish (@RCFP), and American Society of News Editors Counsel Kevin Goldberg (@kevinmgoldberg).

To participate, simply follow @ASNEChat at 2 p.m. and use the hashtag #ASNEChat. You can direct questions to ASNE or any one of the panelists.  Happy tweeting!

Dana Liebelson is POGO's Beth Daley Impact Fellow.

Follow @dliebelson

Image via Flickr user Tim_Cornett

SUNSHINE WEEK: Firm Failed to Respond to Medical Bed Deaths, FDA Doc Shows

By DANA LIEBELSON

As part of Sunshine Week, a national initiative to highlight the importance of open government and freedom of information, POGO is releasing a host documents obtained by the Freedom of Information Act (FOIA). POGO has long investigated issues related to public health, and today's document shows how FOIA can be used to make important information available to the public. Read more about POGO's plans for Sunshine Week here. 

Invacare Corporation, a manufacturer of medical beds, failed to take adequate corrective action even after receiving complaints that their beds allegedly caused multiple consumer deaths, according to a Food and Drug Administration (FDA) inspection report dated August 2010.

The document is part of a broader set of FDA inspection reports in the Los Angeles and Florida districts that POGO obtained via Freedom of Information Act (FOIA) request. Inspections by FDA can be triggered—as in this case—if the agency receives consumer complaints that a medical device is unsafe.

The inspection report states that Invacare “failed to take corrective action in response to reports of entrapment involving Invacare medical beds sometimes resulting in death.”

In one of many complaints to the firm outlined in the document, an Invacare bed and bed rail was allegedly involved in a bed entrapment death of an 11-year-old child—but, despite the death involving its product, Invacare did not get pertinent information such as the bed model number, patient size, and whether there was a history of entrapment with that particular model of bed rail.

POGO Is Celebrating Sunshine Week! Are You?

By DANA LIEBELSON

Today, journalists and advocacy groups across the U.S. are kicking off Sunshine Week, a national initiative to promote good government and freedom of information. Naturally, as a long-time transparency advocate, POGO is organizing a variety of activities to promote the event.  

We’ll be posting new documents obtained through Freedom of Information Act (FOIA) requests throughout the week, as well as cool graphics you can share with your friends and family.

Tomorrow morning, retired Marine Sergeant Jerry Ensminger, subject of the documentary Semper Fi: Always Faithful, will be testifying before the Senate Judiciary Committee for a hearing on FOIA exemptions—an event POGO will cover. Later that afternoon, POGO Executive Director Danielle Brian will participate in a Sunshine Week Twitter chat hosted by the American Society of News Editors at 2 p.m. EST.

Additionally, on Friday, Danielle will moderate a panel in a Freedom Forum discussion, which will be broadcasted live from the Newseum in Washington, DC, on Friday at 2:30 p.m. EST.

Stay tuned on the blog—Louis Brandeis wouldn’t want to miss this coverage, and you shouldn’t either. Feel free to tell us in the comments how you or your organization plan to celebrate! 

Dana Liebelson is POGO's Beth Daley Impact Fellow.

Follow @dliebelson