Agropharma Laboratories, Inc. — FDA Warning Letter Findings

Your firm failed to maintain the buildings used in the manufacture, processing, packing, or holding of a drug product in a clean and sanitary condition (21 CFR 211.56(a)). Drug manufacturing areas at your facility were in disrepair. For example, our investigator observed facility damage such as broken walls in the production area, filth, and pooling water in close proximity to open manufacturing equipment. In response to this letter, provide your corrective action and preventive action (CAPA) plan to implement routine, vigilant operations management oversight of facilities and equipment. This plan should ensure, among other things, prompt detection of equipment/facilities performance issues, effective execution of repairs, adherence to appropriate preventive maintenance schedules, timely technological upgrades to the equipment/facility infrastructure, and improved systems for ongoing management review.

Your firm failed to establish 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)). Your firm has not established that your processes used to manufacture drug products are validated. Additionally, your firm uses water from your water system as a component to manufacture your drug products; however, you have…

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 manufactures over-the-counter antiseptics indicated for open wounds, as well as hand sanitizers 1 labeled for use by healthcare personnel. Your Quality Unit (QU) did not provide adequate oversight for the manufacture of your drug…