Nowrez & Ismail Shukri Company — FDA Warning Letter Findings

Your firm failed to establish and follow an adequate written testing program designed to assess the stability characteristics of drug products (21 CFR 211.166(a)). The records and information you provided did not demonstrate that your firm has an adequate stability program for the OTC drug products that you manufacture. For example, your firm initially provided a stability test report which noted three years of stability data for (b)(4) batch of (b)(4) % Isopropyl Rubbing Alcohol that was tested between 2017 and 2020. When asked recently to provide data to support the expiry period for each drug product formula, your firm responded with stability data for (b)(4) batch of (b)(4) % Isopropyl Rubbing Alcohol that was tested between 2017 and 2020. The stability data you provided failed to show appropriate chemical and microbiological testing was being performed on an ongoing basis to support the (b)(4) expiry period for your OTC drug products shipped after 2017 to present.

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)). Based on the records and information provided, you did not demonstrate that you conducted adequate finished drug product testing on your OTC drug products. For example, the certificates of analysis (COA) you provided, including your (b)(4) % Isopropyl Rubbing Alcohol, did not include an appropriate assay test for active ingredient content or microbiological testing. Full release testing, including strength and identity testing of the active ingredient, must be performed before drug product release and distribution. Without adequate testing, you do not have adequate scientific evidence to assure that your drug products conform to appropriate specifications before release.

Your firm failed to test samples of each component for identity and conformity with all appropriate written specifications for purity, strength, and quality (21 CFR 211.84(d)(1) and 211.84(d)(2)). Based on the records and information provided, you did not demonstrate that you are adequately testing the identity of incoming components used in the manufacture of your OTC drug products. Your response indicates that you do not test your active ingredient, isopropyl alcohol, for…