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 quality unit (QU) did not provide adequate oversight for the manufacture of your over-the-counter (OTC) sun protection factor (SPF) sunscreen drug products. For example, your QU, which includes you and your regulatory consultant, failed to…
2Documentation and records
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. Your firm also failed to prepare batch production and control records with complete information relating to the production and control of each batch of drug product produced (21 CFR 211.100(a) and 21 CFR 211.188). Batch Production…
3Laboratory and QC controls
Your firm failed to conduct, for each batch of drug product, appropriate laboratory testing, as necessary, required to be free of objectionable organisms. Your firm also failed to test an adequate number of batches of each drug product to determine an appropriate expiration date. (21 CFR 211.165(b) and 21 CFR 211.166(b)). You failed to perform microbiological testing on each batch of your finished drug products. In addition, you lacked sufficient stability data to support…
About this record
Extracted automatically from the document US FDA published on 2023-08-29. 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.
