The U.S. Food and Drug Administration (FDA) inspected drug manufacturing facility, Strides Pharma Science Limited at Unit-II, R. S. No.: 32, 33 & 34 PIMS Road Periyakalapet, Puducherry, from January 28 to February 5, 2019. This warning letter summarizes significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. See 21 CFR, parts 210 and 211.
Major point included in warning letter
- The firm Failed to establish an adequate quality control unit with the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging materials, labeling, and drug products (21 CFR 211.22(a)).
- Firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed (21 CFR 211.192).
The destruction of quality-control paperwork by Strides and a lack of adequate documentation that its medicines are safe raise questions about the effectiveness of Strides’s quality unit and the integrity and accuracy of its data. USFDA also specified a shocking revelation “Our investigator also found a blue binder containing CGMP records, including batch records for U.S. drug products, discarded with other records in a 55-gallon drum in your scrap yard. CGMP documents in the binder were dated as recently as January 21, 2019: seven days before our inspection. Your QU did not review or check these documents prior to disposal.”
The uncontrolled destruction of CGMP records, and your lack of adequate documentation practices, raise questions about the effectiveness of quality unit and the integrity and accuracy of your CGMP records.
Learn about USFDA warning letter – 483 observation – date integrity >> Click here