Premier Pharmacy Labs Inc. — FDA 483 Findings

Separate or defined areas to prevent contamination or mix-ups are deficient regarding the manufacturing and processing operations.

Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established and followed.

Acceptance criteria for the sampling and testing conducted by the quality control unit is not adequate to assure that batches of drug products meet each appropriate specification as a condition for their approval and release.

The labels of your outsourcing facility's drug products do not include information required by section 503B(a) (10)(B).

There is a failure to thoroughly review any unexplained d.iscrepancy whether or not the batch has been already distributed.

Approved drug product containers are not retested or reexamined as appropriate for identity, strength, quality and purity after storage for long periods and exposure to conditions that might have an adverse event with subsequent approval or rejection by the quality control unit.

The written stability testing program is not followed.

Establishment of the reliability of the component supplier's report of analyses is deficient in that the test results are not appropriately validated at appropriate intervals.

Equipment and utensils are not maintained and sanitized at appropriate intervals to prevent malfunctions and contamination that would alter the safety, identity, strength, quality or purity of the drug product.