FDA 483 - Packaging Coordinators, LLC - January 31, 2025

Packaging Coordinators, LLC in Philadelphia, PA, was issued a Form 483 following an inspection from January 27-31, 2025, citing significant deficiencies in its quality control unit. The firm failed to adhere to written procedures for managing quarantined and rejected materials, reviewing production and temperature records, initiating deviations promptly, and maintaining consistent cleaning schedules. These findings indicate a serious lack of oversight and compliance within the quality system.