Brands International Corporation — FDA Warning Letter Findings

Your firm failed to test samples of each component for identity and conformity with all appropriate written specifications for purity, strength, and quality. 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 failed to adequately test incoming components, including active pharmaceutical ingredients (APIs), for identity before using them in the…

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)). You failed to adequately test drug products you manufactured, including the identity and strength of each active ingredient prior to release and distribution into the U.S. market. For example, your QU released…

Your firm failed to have buildings used in the manufacture, processing, packing, or holding of drug products with adequate space for the orderly placement of equipment and materials to prevent mixups and contamination (21 CFR 211.42(b)). Your drug manufacturing facility lacked adequate controls. For example: A. Material storage Investigators observed approximately (b)(4) truck trailers on your property used for the storage of components, finished products, and other items…

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). You lacked a QU with appropriate oversight for the manufacture of your drug products. For example, we observed the following deficiencies: A. You failed to establish and implement adequate procedures to validate your processes and qualify the…