WL Blaine Labs Inc MAY 05, 2020
1. Your 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).
A. Your investigations into out-of-specification (OOS) test results were inadequate. For example, you did not adequately investigate the failing viscosity test result obtained at bulk stage of Terpenicol AFC 13% topical cream lot BL2534. Although your Quality Unit (QU) was aware of the drug quality failure, no investigation of manufacturing was performed and the lot was approved for release to customers.
Inadequate investigation of viscosity failures was also cited during our November 2015 inspection...
4. Your firm failed to establish an adequate quality unit and the responsibilities, and procedures applicable to the quality control unit were not in writing and fully followed (21 CFR 211.22(a)&(d)).
Your QU did not fully exercise its authority and responsibilities. Your QU failed to ensure that you have adequate procedures and oversight of your manufacturing activities. For example, you lacked written or approved procedures describing process validation, equipment qualification, OOS investigations, stability program, and change control for your manufacturing processes.
Your firm failed to follow proper documentation practices to ensure the accuracy of your CGMP records. For example, you had multiple versions of your bulk material test report template which were not approved by your QU. In addition, your document change control report did not adequately capture all changes made to your bulk material test report template.
Further, your quality control laboratory personnel used loose paper to document raw test data, which was later transcribed onto test reports. The loose paper was not retained or reviewed, and laboratory notebooks or worksheets were not used. Laboratory personnel signed off on their own test reports without secondary verification.
Your response lacked documentation and sufficient detail to support that you are establishing appropriate operational functions, systems, programs, and related procedures to ensure product quality. You also failed to address the potential impact that your lack of quality oversight had on the quality of all drugs that you manufacture...
