Deqing Jiarou Daily Chemical Co., Ltd. — FDA Warning Letter Findings

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). Your firm manufactured OTC drug products including Antibacterial Hand Sanitizer (b)(4) . 1 Based on the records and information you provided, you did not demonstrate that you are adequately testing the identity of incoming components used in the manufacture of your drug products. You also did not demonstrate that you are testing your active…

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 you provided, you did not demonstrate that you conducted adequate finished drug product testing on your drug products. For example, the certificate of analysis (COA) reports that you provided do not include an appropriate assay test for active ingredient content or impurity 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 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 hand sanitizer drug products that you manufacture. For example, your firm provided a stability test report which only include four weeks of stability data of (b)(4) batch of hand sanitizer. In addition, you failed to provide data demonstrating appropriate chemical and microbiological testing is performed on your drug products during your stability studies.

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)). The records and information you provided demonstrate that your quality unit (QU) did not effectively exercise its responsibilities to oversee the quality of your drug manufacturing operations. Your QU is responsible…