Warning Letter – Violation of cGMP

Prosana Distribuciones S.A. de C.V.
Date:12/18/2017

This warning letter summarizes significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. See 21 CFR, parts 210 and 211. Your March 29, 2017, response to FDA’s inspectional observation was inadequate and did not provide sufficient evidence of corrective actions to bring your operations into compliance with CGMP. For example, you failed to provide: A comprehensive investigation into the extent of the inaccuracies in data records and reporting. Identify omissions, alterations, deletions, record destruction, non-contemporaneous record completion, and other deficiencies. Describe all parts of your facility’s operations in which you discovered data integrity lapses, and evaluate the nature of the data integrity deficiencies.

FDA District: CDRH

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