Cetero, in correspondence with the FDA, conceded misconduct. And in an interview, Cetero's former attorney, Marc Scheineson, acknowledged that chemists at the Houston facility committed fraud but said the problem was limited to six people who had all been fired.
"There is still zero evidence that any of the test results…were wrong, inaccurate, or incorrect," he said. Scheineson called the FDA's actions "overkill" and said they led to the demise of Cetero and its successor company.
In 2012, the company filed for Chapter 11 bankruptcy and emerged with a new name, PRACS Institute. PRACS, in turn, filed for bankruptcy on March 22 of this year. A PRACS spokesperson said the company had closed the Houston facility in October 2012.
Pamidi, the Cetero executive who provided the carts of file boxes, declined to comment.
As for Stone, the former FDA investigator, he said he was disturbed by the agency's decisions.
"They could have done more," he said. "They should have done more."
'We Should Have Been Told'
Cross-checking U.S. and European public records, including regulatory filings, scientific studies and civil lawsuits, ProPublica was able to identify a few of the drugs that are on the U.S. market because of tests performed at Cetero's Houston lab (see chart.) There is no evidence that patients have suffered harm from these drugs; the FDA says it has detected no increase in reports of side effects or lack of efficacy among Cetero-tested medications.
To be sure, just because a crucial study is deemed potentially unreliable does not mean that a drug is unsafe or ineffective. What it does mean is that the FDA's scientific basis for approving that drug has been undermined.
The risks are real, academic experts say, particularly for drugs such as blood thinners and anti-seizure medications that must be given at very specific doses. And generic versions of drugs have been known to act differently from name-brand products (see accompanying story.)
There is no indication the generic ibuprofen gelatin capsules hurt anyone, but their case shows how the FDA left a drug on the market for months without confirmation that the drug was equivalent to the name brand.
The capsules were manufactured by Banner Pharmacaps and carried by Supervalu, a grocery company that operates or licenses more than 2,400 stores across the United States, including Albertson's, Jewel-Osco, Shop 'n Save, Save-A-Lot, and Shoppers Food & Pharmacy.
Cetero had performed a key analysis to show that the capsules were equivalent to other forms of the drug. Banner, the drug's maker, said the FDA first alerted it to the problems at Cetero in August 2011. The FDA required drug companies to redo many of Cetero's tests, but, a spokesperson for Banner wrote in an email, "We received no directive from FDA to recall or otherwise interrupt manufacture of the product."
Banner said it repeated the tainted Cetero tests at a different research firm, and the FDA said it received the new data in January 2012 — leaving a gap of at least five months when the FDA knew the drug was on the market without a rock-solid scientific basis.
An FDA spokesperson wrote in an email that the agency found the new studies Banner submitted "acceptable" and told Banner it had no further questions.
A spokesperson for Supervalu told ProPublica it purchased the ibuprofen from a supplier, which has assured the grocery company that "there are no issues with the product."