Teva Parenteral Medicines, Inc. — FDA 483 Findings

Each lot ofa component liable to objectionable microbiological contamination is deficiently subjected to microbiological tests before use.

Procedures designed to prevent microbiological contamination ofdrug products purporting to be sterile are not established and written.

In-process materials are not tested for qnality and purity and approved or rejected by the qua.lity control unit during the production process.

Investigations of all unexplained discrepancy did not extend to other batches of the same drug product and other drug products that may have been associated witb the specific failure Of discrepancy.

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

There is a failure to thorougWy review any unexplained discrepancy whether or not the batch has been already distributed.

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

The quality control unit lacks responsibility to approve and reject all procedures or specifications impacting on the identity, strength, quality, and purity of drug products.

Records are not kept for the cleaning and sanitizing of equipment.

Each batch ofdrug product required to be free ofobjectionable microorganisms is not tested tbrough appropriate laboratory testing.

The responsibilities and procedures applicable to the quality control unit are not·in writing.

Equipmenlused in the manufacture, processing, packing or holding ofdrug products is not ofappropriate design to facilitate · operations for its intended use.