L. Perrigo Co. — FDA 483 Findings

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

There was a failure to handle and store components at all times in a manner to prevent contamination.

Reserve drug product samples are not representative of each lot or batch of drug product.

The responsibilities and procedures applicable to the quality control unit are not fully followed.

Inspection of the packaging and labeling facilities immediately before use is not done to assure that all drug products have been removed from previous operations.

Investigations of an unexplained discrepancy did not extend to other batches of the same drug product and other dru g products that may have been associated with the specific failure or discrepancy.

Reserve samples from representative sample lots or batches of drug products selected by acceptable statistical procedures are not examined visually 8.t least once a year for evidence of deterioration.

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