Findings
1Material 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 perform adequate identity testing of each component lot used in the manufacture of your OTC drug products. You also relied on your…
2Data integrity
Your firm failed to exercise appropriate controls over computer or related systems to assure that only authorized personnel institute changes in master production and control records, or other records (21 CFR 211.68(b)). Your stand-alone gas chromatogram (GC) computer system lacked appropriate controls, such as an audit trail and individual log-in access to prevent the deletion of data. For example, investigators found numerous analysis reports, test methods, raw data…
3Process 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 design, monitor, and maintain your water system to ensure it was suitable for use in the manufacture of your drug products. Your (b)(4) water system was not continuously circulated, and the…
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)). Your firm manufactures over-the-counter (OTC) hand sanitizers drug products.1 Your firm failed to adequately test batches of your hand sanitizer drug products for the identity and strength of your active…
About this record
Extracted automatically from the document US FDA published on 2024-06-18. 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.
