"...Des enregistrements de laboratoire incomplets,inexacts ou falsifiés".
3. Your firm failed to ensure that laboratory records included complete data derived from all tests necessary to assure compliance with established specifications and standards (21 CFR 211.194(a)). During our inspection, we observed multiple examples of incomplete, inaccurate, or falsified laboratory records. a. EM records for active air monitoring of the aseptic filling area reported samples as being collected when they were not actually collected, and some records documented purported EM results of zero colony forming units (CFU) even when the samples for which those results were reported were not actually collected....
b. Our review of EM records from January 2014 through September 2014 found that no samples had exceeded the action levels for any of the (b)(4) filling lines in your (b)(4) plant, or for the filling line in Plant (b)(4). However, we observed 12 microbiological plates in the incubator showing EM results that required further action during our inspection of your laboratory...
Furthermore, data falsification and manipulation, and your reliance on incomplete records to release product to the market, are repeat violations. A February 2014 inspection of solid (b)(4) dosage operations at this same facility also reported data manipulation and falsification of test results generated by your firm, along with other deficient laboratory practices that also resulted in products being recalled from the U.S. market. In your 2014 response, you made a similar commitment to hire a third party auditor to conduct a comprehensive audit of all laboratory electronic and hard copy data for tests conducted for all release and stability finished product. Our 2015 inspection found continuing practices of data falsification and manipulation at your facility, indicating that previous corrections were ineffective.
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