Signature Formulations, LLC — FDA Warning Letter Findings

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. Your firm failed to conduct, for each batch of drug product, appropriate laboratory testing, as necessary, required to be free of objectionable microorganisms (21 CFR 211.165(a) and 211.165(b)). You released finished drug…

Your firm failed to clean, maintain, and, as appropriate for the nature of the drug, sanitize and/or sterilize equipment and utensils at appropriate intervals to prevent malfunctions or contamination that would alter the safety, identity, strength, quality, or purity of the drug product beyond the official or other established requirements (21 CFR 211.67(a)). You failed to ensure your cleaning procedures are adequate to prevent cross-contamination of (b)(4) OTC drug products…

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)). You lacked adequate quality unit (QU) oversight for the manufacture of your drug products. For example, your QU failed to ensure: Adequate testing of incoming raw materials, including performing identity testing of each shipment of each component (e.g. (b)(4) ) used in the…

Your firm failed to perform operations within specifically defined areas of adequate size and to have separate or defined areas or such other control systems necessary to prevent contamination or mix-ups (21 CFR 211.42(c)). You manufacture (b)(4) over-the-counter (OTC) (b)(4) drug products and (b)(4) containing drug products in a shared facility, using multiple pieces of shared equipment. For example, (b)(4) was used to manufacture (b)(4) containing (b)(4) prior to…