Vitae Enim Vitae Scientific Inc. — FDA Warning Letter Findings

Your firm failed to establish and follow appropriate written procedures that are designed to prevent microbiological contamination of drug products purporting to be sterile, and that include validation of all aseptic and sterilization processes (21 CFR 211.113(b)). Smoke Study Deficiencies Your procedures did not include a requirement for smoke studies to be performed in ISO 5 classified areas. You also failed to perform smoke studies prior to the inspection. You performed a…

Your firm failed to thoroughly investigate any unexplained discrepancy or failure of a batch or any of its components to meet any of its specifications, whether or not the batch has already been distributed (21 CFR 211.192). You lacked adequate investigations, including insufficient root cause determination and failure to expand investigations to all potentially affected batches. For example, your deviation report stated, “when transferring (b)(4) from formulation vessel to…

Your firm failed to establish and follow adequate control procedures to monitor the output and to validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product (21 CFR 211.110(a)). You failed to adequately inspect your sterile drug products for visible defects and contamination. Your limited post-fill visual inspection of aseptically filled drug products was…

You 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). Inadequate oversight of contract testing laboratory Your Quality Unit (QU) failed to provide adequate oversight of your contract testing laboratory. For example, you failed to ensure analytical and microbiological test methods used by your…