PharMEDium Services, LLC. — FDA 483 Findings

Employees engaged in the manufacture, processing, packing and holding of a drug product lack the training required to perform their assigned functions.

The quality control unit lacks authority to review production records to assure that no errors have occurred and fully investigate errors that have occurred.

Drug products do not bear an expiration date determined by appropriate stability data to assure they meet applicable standards of identity, strength, quality and purity at the time of use.

Drug product production and control records, are not reviewed and approved by the quality control unit to determine compliance with all established, approved written procedures before a batch is released or distributed.

The labels of your outsourcing facility's drug products are deficient.

Written procedures are not followed that describe the tests and examinations to be conducted on appropriate samples of in-process materials of each batch.

Procedures describing the handling of all written and oral complaints regarding a drug product are not followed.

There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed.

Buildings used in the manufacture, processing, packing, or holding of a drug product do not have the suitable construction and loation to facilitate cleaning, maintenance, and proper operations.

Input to and output from the computer, related systems of formulas and records or data not checked for accuracy.

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Samples taken of drug products for determination of comfonnance to written specifications are not representative.

Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include adequate validation of the sterilization process.