Findings
1Process 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 (21 CFR 211.100(a)). Your firm has not established that your processes used to manufacture your drug products are appropriately validated. You failed to conduct process validation studies for numerous drug products you manufactured and…
2Equipment and facility
Your firm failed to establish and follow an adequate written testing program designed to assess the stability characteristics of drug products and to use results of stability testing to determine appropriate storage conditions and expiration dates (21 CFR 211.166(a)). You failed to demonstrate that you established and followed an adequate stability program to determine appropriate storage conditions and expiration dates of drug products manufactured at your facility. For…
3Material and supplier control
Your firm failed to test samples of each component for identity and conformity with all appropriate written specifications for purity, strength, and quality. Your firm also failed to validate and establish the reliability of your component supplier’s test analyses at appropriate intervals (21 CFR 211.84(d)(1) and 211.84(d)(2)). You failed to adequately test your incoming components for identity before using the components to manufacture your over-the-counter (OTC) drug…
About this record
Extracted automatically from the document US FDA published on 2023-02-14. 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.
