Dyno Manufacturing, Inc. — FDA Warning Letter Findings

Your firm failed to assure that the drug product bore an expiration date that was supported by appropriate stability testing (21 CFR 211.137(a)). You failed to establish a stability testing program to support the expiry of your distributed drug products. You did not perform any stability studies for your OTC hand sanitizer and antibacterial hand soap drug products to support their assigned (b)(4) expiry period. Also, you did not have an approved stability program procedure…

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 quality unit (QU) did not adequately exercise its authority and responsibilities including, but not limited to, implementing effective procedures and conducting adequate oversight. For example, you failed to ensure the following…

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)). You failed to validate your production and process controls. You did not have assurance that you are capable of consistently manufacturing your drug product with defined quality attributes. Your firm lacked a…

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)). Your firm manufactures over-the-counter (OTC) hand sanitizer and antibacterial hand soap drug products without adequate assurance of the quality of raw materials. For example, you did not adequately…