Findings
1Equipment and facility
Your firm failed to maintain buildings used in the manufacture, processing, packing, or holding of drug products in a good state of repair (21 CFR 211.58). Our investigator observed a black mold-like substance at the base of the hose reel and behind the water storage tank in the (b)(4) clean out of place (b)(4) room. The black substance was within one foot of stainless-steel pails and other product-contact equipment used for OTC drug production. The base of the wall behind…
2Equipment and facility
Your firm failed to follow appropriate written procedures, designed to prevent objectionable microorganisms in drug products not required to be sterile (21 CFR 211.113(a)). Microbiological Results in Water Samples and Finished Product Your firm produced (b)(4) water and used it as a component in your OTC drug products and as a final rinse after equipment cleaning. A. You recovered Pseudomonas aeruginosa in multiple (b)(4) water samples, from June 2021 to October 2022. This…
3Complaint and recall handling
Your firm failed to establish and follow adequate written procedures describing the handling of all written and oral complaints regarding a drug product, including provisions for review by the quality control unit of any complaint involving the possible failure of a drug product to meet any of its specifications and, for such drug products, a determination as to the need for an investigation in accordance with 21 CFR 211.192 (21 CFR 211.198(a)). Your complaint procedure is…
About this record
Extracted automatically from the document US FDA published on 2024-11-19. 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.
