Atlantic Management Resources LTD dba. Claire Ellen Products — FDA Warning Letter Findings

Your firm failed to prepare batch production and control records that include documentation of the accomplishment of each significant step in the manufacture, processing, packing, or holding of the batch, for each batch of drug product (21 CFR 211.188(b)). Your firm failed to have batch and control records that document your manufacturing operations. You stated that there were no batch records and no batch numbers. Batch records are required to capture significant…

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 (d)). Your firm failed to establish a quality unit (QU) with the responsibilities and authority to oversee the manufacture of your homeopathic drug products. You stated that your firm does not have any written procedures, including those that govern quality operations. For example…

Your firm failed to store drug products under appropriate conditions of temperature, humidity, and light so that the identity, strength, quality, and purity are not affected (21 CFR 211.142(b)). You failed to have adequate storage and warehousing of drug products. For example, although a supplier’s certificate of analysis (COA) for a bulk drug stated that the drug is sensitive to heat, sunlight, and moisture, you failed to monitor storage conditions for the drug, including for temperature and humidity. You also acknowledged that there were inadequate storage conditions for drug products, and for your containers and closures. The holding of drug products must be performed under appropriate conditions so that the identity, strength, quality, and purity are not affected.