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Audit, Formation et Accompagnement de vos projets réglementés
vendredi 3 janvier 2020
WARNING LETTER Cross Brands Contract Filling, LLC MARCS-CMS 589295 — DECEMBER 17, 2019
2. Your firm lacks an adequate quality control unit with adequate facilities and procedures to ensure that drugs are manufactured in compliance with CGMP regulations and meet established specifications for identity, strength, quality, and purity (21 CFR 211.22).
During the inspection, we observed that your Quality Unit (QU) did not provide adequate oversight over the manufacture of your drug products. For example, you lacked adequate written procedures describing your manufacturing operations and you failed to ensure that all batch and laboratory records are complete.
Our inspection found that your QU misrepresented results for the absence of Staphylococcus aureus and Pseudomonas aeruginosa on COA that were released to your customers. Your QU allowed distribution of these products.
Without complete laboratory and batch records, and adequate procedures, you cannot ensure the accuracy and reliability of your data.