FDA 483 - Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC - September 19, 2023

During an inspection conducted from September 6 to September 19, 2023, the FDA issued a Form 483 to Wyeth BioPharma Division of Wyeth Pharmaceuticals LLC, a biological drug substance manufacturer in Andover, MA. The inspection revealed three significant observations indicating potential deviations from regulatory expectations. Firstly, the company's batch record allowed for operations outside target criteria using production options, with Continuous Process Verification (CPV) data exclusions improperly justified, suggesting potential process variability. Secondly, shipping containers used for transporting biological drug substances failed to maintain the required temperature range. Multiple temperature excursions were attributed to defective door gaskets, and physical modifications to a container model, deemed functionally equivalent, lacked validation for temperature maintenance. Finally, the firm's classification of a particular attribute as "non-CQA" for its drug substance was deemed unjustified. This designation appeared historical rather than risk-based, despite its influence on product safety and efficacy and its control through key manufacturing processes. As a result of these observations, documented under the Federal Food, Drug, and Cosmetic Act, Wyeth BioPharma is expected to develop and implement comprehensive corrective and preventive actions to ensure compliance and product quality.