Your firm failed to establish an adequate quality control unit with the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging materials, labeling, and drug products (21 CFR 211.22(a)). Your quality unit (QU) failed to ensure the chemical and microbial testing methods performed by your contract laboratory for finished drug product release testing and water system monitoring were not adequately…
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)). You failed to perform adequate incoming testing of each component lot used in the manufacture of your OTC drug products, such as Therabreath Mild…
3Deviation, CAPA, and investigation
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). On over 60 occasions, your firm isolated objectionable microorganisms (e.g., Burkholderia, Pseudomonas, Staphylococcus, Bacillus , and Aspergillus species) from your (b)(4) water system used as a component to manufacture over-the-counter (OTC) drug…
4Equipment and facility
Your firm failed to clean, maintain, and, as appropriate for the nature of the drug, sanitize and/or sterilize equipment and utensils at appropriate intervals to prevent malfunctions or contamination that would alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements (21 CFR 211.67(a)). You failed to demonstrate your cleaning and disinfection practices are adequate to remove all contaminants from the…
About this record
Extracted automatically from the document US FDA published on 2025-02-11. 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.
