483
Pharmetric Laboratory LLCFDA 483 - Pharmetric Laboratory LLC - November 06, 2023
Record Details
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.
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ID · b84d19b3-7912-42fe-9a32-be7df778d584