FDA 483 - Pharmetric Laboratory LLC - November 06, 2023

An FDA inspection of Pharmetric Laboratory LLC, a contract testing laboratory in St Petersburg, FL, revealed significant deficiencies within its Quality Control unit. The unit failed to identify issues including incomplete non-conformance logs, untimely investigations, inadequate separation of quarantined materials, and an analyst's non-compliance with documentation procedures for endotoxin analysis. These findings indicate a lack of adherence to established quality control responsibilities and procedures.