Findings
1Stability and storage
Your firm failed to establish an adequate written testing program designed to assess the stability characteristics of drug products (21 CFR 211.166(a)). Your stability program was not adequate to ensure that the OTC drug products you manufacture maintain their identity, strength, quality, purity, and safety throughout their shelf lives. For example, full shelf-life studies were not conducted for the entire stated expiry period. Additionally, the studies performed lacked…
2Laboratory and QC controls
Your firm failed to establish laboratory controls that include scientifically sound and appropriate specifications designed to assure drug products conform to appropriate standards of identity, strength, quality, and purity. Your firm also failed to have, for each batch of drug product, an appropriate laboratory determination of satisfactory conformance to final specifications for drug products prior to release (21 CFR 211.160(b) and 211.165(a)). Your firm manufactures…
3Quality 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) is inadequate. Your QU did not provide adequate oversight for the manufacture of your OTC drug products. For example, your QU failed to ensure: Review of production and control records to ensure completeness and accuracy…
About this record
Extracted automatically from the document US FDA published on 2025-11-25. 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.
