FDA Plans to Get Tough on Poor Data Integrity

The FDA intends to step up its scrutiny of a company’s data integrity protections during manufacturing inspections, following a series of investigations that caught drugmakers backdating manufacturing records and falsifying data.

The FDA is focusing on the issue because a single data integrity issue calls into question all the data produced by a company, FDA officials said.

Investigators are already citing an increasing number of drugmakers for data integrity failures, with non-U.S. facilities experiencing most of the problems, agency representatives said at the Food and Drug Law Institute’s current good manufacturing practices conference in Washington, D.C.

In fiscal year 2013, eight of the 26 warning letters the agency issued to foreign manufacturers cited data integrity. In 2014, 12 of 13 warning letters issued to date have found problems with data integrity.

Alicia Mozzachio, chief of the international compliance branch of the Office of Manufacturing and Product Quality, said the top data integrity issues observed during inspections are:

• Not recording activities contemporaneously;
• Backdating documents. The agency response to this varies depending on the document in question. For example, a one-time backdating of an equipment calibration record may not be as severe as backdating a record of an analytical test method, said Mozzachio;
• Fabricating data. Outright fabrication of data can be extremely challenging for FDA investigators to detect, she said, and is treated very seriously by the agency; and
• Copying data from past records and fraudulently reporting it as new data.

Once such activities are uncovered, the FDA demands rigorous efforts to prove a company has corrected its problems. The best way for a company to get back into compliance is to conduct a comprehensive audit of the data controls in its systems, said Thomas Cosgrove, acting director of the Office of Manufacturing and Product Quality, and conduct ongoing review to ensure changes are effective.

“We want to see sustained periods of reliable data,” Cosgrove said after the session. “What we are looking to avoid is quick fixes that don’t reflect true underlying changes.”

The FDA has started to emphasize in warning letters the importance of hiring third-party auditors to conduct such data integrity reviews, Mozzachio added.

Last month, for example, the FDA recommended Canadian generics maker Apotex conduct such an audit of its plant in Bangalore, India, when it issued a warning letter citing rampant problems with data manipulation, including continuously retesting batches until the desired result is achieved.

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