Findings
1Material 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 (2)). You failed to adequately test your incoming components for identity before using them to manufacture your drug products. Identity testing for each component lot used in drug product manufacturing is required…
2Deviation, CAPA, and investigation
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 firm lacks a QU and approved written procedures defining QU responsibilities and controls. You failed to establish procedures describing critical oversight responsibilities including, but not limited to, deviations and investigations…
3Documentation 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) Process Validation…
4Laboratory and QC controls
Your firm failed to have, for each batch of drug product, appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient, prior to release (21 CFR 211.165(a)). You failed to perform adequate release testing for each batch of your drug product prior to distribution. Your firm released multiple batches of over the counter (OTC) Mr. Lulu Sunscreen Drops SPF32 to the…
About this record
Extracted automatically from the document US FDA published on 2023-06-06. 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.
