Des écarts documentaires...
2. Failure of your quality unit to prepare, review, and approve documents related to the manufacturing of API.
On August 16, 2016, our investigators found a large number of trash bags behind a building on your property. The trash bags contained torn original laboratory and production records, such as analytical test reports, (b)(4) water testing reports, and sample notebooks. The information on these discarded, torn documents did not match the official records. Your quality unit did not investigate these discrepancies. On August 18, 2016, when our investigators revisited the area where the trash bags had been, they found that the documents had been removed from the site. These findings indicate that your quality unit is not exercising its responsibilities...
3. Failure of your quality unit to exercise its responsibility to ensure the API relabeled at your facility are in compliance with CGMP.
Your relabeling operation was not documented adequately. You did not document the time and date of relabeling operations, nor the employee who conducted relabeling operations for API you distributed. You did not sign and date records at the same time the activites were performed.
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