Findings
1Quality unit oversight
Your firm’s quality control unit failed to exercise its responsibility to ensure drug products manufactured are in compliance with CGMP, and meet established specifications for identity, strength, quality, and purity (21 CFR 211.22). Your QU did not provide adequate oversight for the manufacture of your OTC drug products. For example, you were unaware of numerous CGMP requirements and failed to establish written procedures including, but not limited to, process validation…
2Laboratory and QC controls
Your firm failed to ensure that laboratory records included complete data derived from all tests necessary to ensure compliance with established specifications and standards (21 CFR 211.194(a)). Your laboratory records do not include complete testing data to support the testing performed. For example, your records lack a statement of methods used for testing, a statement of the results of tests and how they compare to the established specifications, a record of all critical…
3Process validation
Your firm failed to establish adequate written procedures for production and process control designed to assure that the drug products you manufacture have the identity, strength, quality, and purity they purport or are represented to possess, and to follow all of your written production and process control procedures (21 CFR 211.100(a) and 211.100(b)). Lack of Process Validation You failed to provide data to demonstrate that you adequately validate your manufacturing…
About this record
Extracted automatically from the document US FDA published on 2024-04-09. The source is available at the link above.
This is a record of that moment. Inspection findings are usually followed by the company's response and corrective action, but this page does not know how that turned out. Do not read it as the current state; check the regulator's official announcements for the latest status.
Translation and classification are automated and may differ in nuance from the source.
