FDA 483 - Symbiosis Pharmaceutical Services Limited - June 13, 2023

From June 5 to June 13, 2023, the FDA inspected the Symbiosis Pharmaceutical Services Limited facility in Stirling, United Kingdom. This inspection of the sterile drug manufacturing site resulted in an FDA Form 483 detailing seven primary observations regarding failures to meet current Good Manufacturing Practice (cGMP) standards. A significant portion of the report focuses on aseptic process violations, where video footage revealed operators moving rapidly in sterile zones, failing to sanitize hands, and sitting on cleanroom floors. These behaviors were inconsistent with the firm’s recorded documentation, raising concerns about microbial contamination risks. Data integrity issues were also prominent; investigators discovered original, signed, and partially completed manufacturing records and product labels discarded in shredder bins rather than being properly archived. Furthermore, the firm’s quality unit failed to maintain a dedicated reserve sample program or a reliable stability testing protocol that mirrors actual storage conditions. Additional facility maintenance issues included unaddressed water system leaks, tank corrosion, and the discovery of dead insects within cleanroom light fixtures. To comply with regulatory requirements, Symbiosis must submit a formal response to the FDA outlining comprehensive corrective and preventive actions. Failure to address these systemic deficiencies in quality oversight and facility maintenance may lead to further enforcement actions, such as a formal warning letter or restrictions on product distribution.