Findings
1Equipment 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 that your cleaning and disinfection practices are adequate to remove contaminants from…
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). Your quality unit (QU) failed to conduct an adequate investigation into a complaint received for a “fishy” odor in your Foaming Waterless Hand Sanitizer 1 lot #713588. Your investigation stated that you “checked inventory in the warehouse and noticed the…
3Laboratory and QC controls
Your firm failed to conduct at least one test to verify the identity of each component of a drug product (21 CFR 211.84(d)(1)). You lacked appropriate identity testing for your incoming components used to manufacture your drug products. For example, your firm did not ensure that at least one specific identity test was conducted for each lot of your drug product components citric acid and carbomer. Additionally, your identity test methods for glycerin, and ethyl alcohol…
4Laboratory 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)). Your laboratory sampling plans and testing methods were not scientifically sound. You collected…
About this record
Extracted automatically from the document US FDA published on 2022-06-07. 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.
