Drivergent, Inc. — FDA Warning Letter Findings

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 211.84(d)(2)). Component Testing You failed to conduct an adequate identity test on each shipment of each lot of components used in the production of your drug products, including the active ingredient (i.e., ethyl…

Your firm failed to establish an adequate quality unit and the responsibilities and procedures applicable to the quality control unit are not in writing and fully followed (21 CFR 211.22(a) and 211.22(d)). Your quality unit (QU) did not provide adequate oversight for the manufacture of your drug products. For example, your QU failed to ensure: Adequate procedures describing roles and responsibilities of the QU, including the handling of vendor qualification, batch release…

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)). Your firm manufactures over-the-counter (OTC) drug products such as hand sanitizer. 2 You failed to adequately test your OTC drug product, DRIVERGENT HAND SANITIZER 80% Alcohol Antiseptic Topical Hand Rub Non-Sterile Solution, for the identity and strength of each active ingredient prior to release for distribution. Testing is an essential part of CGMP to ensure that the drug products you manufacture conform to all pre-determined quality attributes appropriate for their intended use. Drug products must be tested for identity, strength, quality, and purity prior to release and distribution. Without adequate testing, there is no scientific evidence to assure that your drug product conforms to appropriate specifications before release.

Your firm failed to maintain buildings used in the manufacture, processing, packing, or holding of drug products in a good state of repair (21 CFR 211.58). Our investigators observed paint peeling on the ceiling, flakes of paint dropping from the ceiling onto the floor, and several flakes of paint on top of the mixing tote in the production area where you manufacture drug products. Ingredients are added to this mixing tote through an opening in the top of the container. It is essential that your facility is in a good state of repair and sanitary conditions are maintained to protect drug products from potential routes of contamination.