Findings
1Cleaning 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)). You failed to adequately validate your production and process controls. During the inspection, you acknowledged that you did not conduct process validation studies and cleaning validation studies for your…
2Stability and storage
Your firm failed to follow a 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 follow your written stability procedures for your OTC drug products. During the inspection you stated that you used expiration dates provided by your clients but were unable to provide documentation to support those…
3Material and supplier control
Your firm failed to conduct at least one test to verify the identity of each component of a drug product. 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 in your OTC drug products, including propylene glycol and active pharmaceutical ingredients such as…
About this record
Extracted automatically from the document US FDA published on 2024-07-16. 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.
