The FDA placed one of Wockhardt's Indian plants on an import alert in May when it found, among other problems, that it was hiding data about test failures from the FDA. And last month German drugmaker Fresenius Kabi fired the managers at an Indian facility for essentially the same thing. However, the data-manipulation trend in India continues.
This time, an FDA warning letter to an Indian drugmaker says a quality-control chemist admitted he "had recorded false visual examination data in the logbooks for reserve samples" at the order of a manager. The observation was made during a March inspection of the Posh Chemicals plant in Hyderabad. The FDA posted the warning letter this week to its website. The agency has asked for a thorough investigation into the extent of the falsification, the role played by the manager and how the API maker intends to prevent future problems.
That was not the only record-keeping concern the FDA found. It also found that there were no restrictions to access lab data tied to testing equipment and no audit trails to follow, raising questions about whether other employees may have altered or deleted test results.
Computer problems and data falsification were concerns raised during both the Wockhardt and Fresenius Kabi inspections. Inspectors at the Wockhardt plant noted that a convenient computer crash led to the loss of some key data. At Fresenius, workers confessed that during the January inspection and previous inspections, high-pressure liquid chromatography equipment and personal computers were removed from the plant to "conceal data manipulations." The warning letter to Posh found other issues, including that the lab didn't even note "a trend in the total impurity test results reported for this API."
The FDA has been beefing up its foreign inspection team, trying to keep up with the growing number of manufacturers of both APIs and finished products outside the U.S. In its budget "justification" document for next year, the agency pointed out that inspections of foreign manufacturers jumped 10% last year to 813 inspections in 62 countries. The agency said nearly half of the 46 warning letters issued to foreign manufacturers resulted from inspections by its global staff. The agency is also initiating a pilot program that would allow approved drugmakers speedier imports if they met certain standards, allowing the agency to then concentrate its efforts on trouble spots.
- here's the warning letter
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