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A. Ratlam facility (FEI: 3002807297)
1. Failure to have computerized systems with sufficient controls to prevent unauthorized access or changes to data.
During the inspection, FDA investigators discovered a lack of basic laboratory controls to prevent changes to your firm’s electronically stored data. Your firm relied on incomplete records to evaluate the quality of your drugs and to determine whether your drugs conformed with established specifications and standards...
2. Failure to adequately investigate and resolve critical deviations.
Our inspection documented that your firm’s quality unit was aware of the lack of controls in your computerized systems to prevent the manipulation and deletion of quality-related data. Your site’s senior management failed to take sufficient corrective action and prevent the recurrence of these problems...
3. Failure to follow and document laboratory controls at the time of performance; failure to document and explain any departures from laboratory procedures.
During the inspection of your microbiology laboratory, our investigators observed multiple examples of your firm’s practice of back-dating and falsifying laboratory data...
B. Pithampur (FEI: 3007574780)
1. Your firm failed to ensure that laboratory records include complete data derived from all tests necessary to assure compliance with established specifications and standards. (21 CFR 211.194(a))
We found documented instances of analytical test results without original data. For example, your raw data is incomplete for GC analysis performed during the (b)(4) method verification for (b)(4) USP (raw material) and (b)(4) (raw material)....
C. Piparia Silvassa (FEI 3005977675)
1. Your firm failed to ensure that laboratory records included complete data derived from all tests necessary to assure compliance with established specifications and standards. (21CFR 211.194(a))
During our inspection, we documented that your QC laboratory was conducting trial injections of samples but failed to report all of the data generated...
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