Findings
1Quality unit oversight
Your firm failed to establish and follow adequate written procedures for cleaning and maintenance of equipment (21 CFR 211.67(b)). Our investigators documented several deficiencies in your equipment maintenance and cleaning program. For example, a leak was observed from a pump within the water purification system. A work order dated May 7, 2021, documented the leak but as of the date of the inspection, the quality unit (QU) had not been notified of the leak, as required by…
2Complaint and recall handling
Your firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed (21 CFR 211.192). You failed to adequately investigate OOS results and complaints. For example: • B. cepacia was found in your Topical Fungicide Formula lot (b)(4) . You destroyed this lot, but you did not adequately investigate the root cause of the microbial…
3Laboratory and QC controls
Your firm failed to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity (21 CFR 211.160(b)). You manufacture over-the-counter (OTC) drug products including benzalkonium chloride-based hand…
About this record
Extracted automatically from the document US FDA published on 2022-04-19. 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.
