Advanced Pharmaceutical Technology — FDA Warning Letter Findings

Your firm failed to establish adequate written procedures for production and process control designed to assure that the drug products you manufacture have the identity, strength, quality, and purity they purport or are represented to possess (21 CFR 211.100(a)). Your firm manufactures (b)(4) sterilized, (b)(4) . You lacked adequate scientific rationale to demonstrate that your drug manufacturing processes are appropriately validated, reproducible, and controlled to…

Your firm failed to establish an adequate quality control unit with the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging materials, labeling, and drug products (21 CFR 211.22(a)). Contract Testing Laboratories Your quality unit (QU) did not exercise its responsibility to oversee your contract testing laboratory to ensure the appropriate finish product testing was being conducted. For example…

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 sterilization processes (21 CFR 211.113(b)). You lacked appropriate controls to ensure the sterility of (b)(4) drug products that purport to be sterile. For example, you relied on the (b)(4) sterilization process without monitoring pre-sterilization bioburden. In…

Your firm failed to have, for each batch of controlled-release dosage form, appropriate laboratory determination of satisfactory conformance to the specifications for the rate of release of each active ingredient (21 CFR 211.167(c)). You failed to provide adequate data demonstrating your drug products, (b)(4) , have a (b)(4) of the active ingredient. For example, you claim your (b)(4) lasts for up to (b)(4) and that your (b)(4) products have (b)(4) effect for (b)(4) . Your…