Resilience US, Inc. – FDA 483, Nov 13, 2009

The FDA Form 483 details numerous observations at a US Therapeutics facility, specifically referencing operations at Allston Landing. Key issues include a lack of a standard operating procedure for periodic review of deviations and investigations by the Quality Unit, leading to insufficient overall assessment of their impact on manufacturing and quality controls. Investigations into particulate matter in finished drug product failed to identify corrective actions for visual inspection deficiencies.

Equipment design is noted as inappropriate for its intended use, and control procedures are not established to monitor or validate manufacturing processes causing variability. Inadequate investigations were conducted for returned drug products implicating associated batches. Aseptic filling processes and personnel qualification procedures (VP-026-15, MYF-001-07) are not consistently followed, with discrepancies in media fill requirements and operator qualification.

Documentation in batch records is insufficient, and investigations are incomplete. The decontamination plan for Vesivirus 2117 contamination (AIR 1871) requires more aggressive implementation. Environmental monitoring lacks documented rationale for sampling locations, and non-viable particle measurements are not taken during routine dynamic operations in the Filtration Room #FF2-09. Visible particles were observed in an air return duct.

Airflow pattern evaluations are missing for sterility test isolators. The Cerezyme manufacturing process has not been updated to reflect cGMPs, and process validation is incomplete. Quality Assurance oversight is insufficient. Raw material issues include no tracking/trending of failed incoming materials and inadequate identity testing