Sanitizer Supply LLC — FDA Warning Letter Findings

Your firm’s quality control unit failed to exercise its responsibility to ensure drug products manufactured are in compliance with CGMP, and meet established specifications for identity, strength, quality, and purity (21 CFR 211.22). Your firm’s quality systems are inadequate. Your firm failed to establish an adequate quality unit (QU) with responsibilities to ensure adequate oversight for the manufacture of your drug products. For example, your QU failed to train and ensure…

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)). You manufacture over-the-counter (OTC) drug products including benzalkonium chloride-based (BZK) hand sanitizing wipes and alcohol-based hand sanitizers and repackage hand sanitizer drug products under contract. 1 You failed to perform potency and microbial testing for your BZK hand sanitizing wipes prior to release for distribution. You released your BZK hand sanitizing wipes based on a (b)(4) . Additionally, in your signed affidavit, you stated that you did not have final product testing results for BZK hand sanitizing wipes. Testing is essential to ensure that the drug products you manufacture conform to all pre-determined quality attributes that are appropriate for their intended use, including microbiological specifications.

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 (2)). You failed to test incoming components and active ingredients (e.g., BZK) for identity. This was confirmed in your signed affidavit provided to our investigator. Your firm relied on the certificates of analysis (COA) from unqualified suppliers without establishing the reliability of each of your suppliers’ COA for the component specifications and characteristics. Identity testing is required for each component lot prior to use in drug product manufacturing, and you can only rely on a COA for other component attributes through validation of supplier’s test results at appropriate intervals.