Bodywell Natural Skin Care Inc. — FDA Warning Letter Findings

Your firm failed to establish adequate written procedures for production and process control designed to assure that the drug products you manufacture have the identity, strength, quality, and purity they purport or are represented to possess (21 CFR 211.100(a)). The records and information you provided did not demonstrate that your processes used to manufacture drug products are validated. Specifically, you state that although your SOPs for production, cleaning, and…

Your firm failed to conduct at least one test to verify the identity of each component of a drug product. 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 21 CFR 211.84(d)(2)). Your firm manufactures OTC drug products including, Prosana Skin & Body Hand Sanitizer Gel and DERMALERE Advanced Burn and Scar Cream. Based on the records and information you provided, you did…

Your firm failed to prepare batch production and control records that include documentation of the accomplishment of each significant step in the manufacture, processing, packing, or holding of the batch, for each batch of drug product (21 CFR 211.188(b)). The batch records you provided in response to our request for records lacked adequate production details, including, but not limited to: Sampling information Actual and theoretical yield calculations Identification and…

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 conduct adequate finished drug product testing on your drug products. Specifically, the COA reports and batch records 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.