Findings
1Stability and storage
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)). Your firm lacked stability data to support the expiration dates for your (b)(4) drug product which is currently in distribution. This is a repeat observation from your 2016 FDA inspection. Instead, to support…
2Material 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)). Your firm failed to test incoming active pharmaceutical ingredients (e.g., camphor and menthol) and other components (e.g., deionized (DI) water)…
3Documentation and records
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) failed to review batch records before releasing drug product for distribution. Your QU procedure specifies that the Quality Assurance designee is responsible for reviewing all manufacturing, production, and quality…
4Process 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 failed to validate the manufacturing process for (b)(4) drug product currently in distribution. This is a repeat observation from your 2016 FDA inspection. In your response, you stated that the validation…
About this record
Extracted automatically from the document US FDA published on 2022-07-26. 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.
