APP Pharmaceuticals — FDA 483 Findings

Laboratory controls do not include the establishment ofscientifically sound and appropriate sampling plans and test procedures designed to assure that drug products confonn to appropriate standards ofideutity, strength, quality and purity.

Procedures designed to prevent microbiological contamination ofdtug products purporting to be sterile do not include adequate validation ofthe sterilization process.

Reserve samples from representative sample lots or batches of drug products selected by acceptable statistical procedur es are not examined visually at least once Redacted (b)(4) for evidence of deterioration.

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

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 and appropriate statistical quality control criteria as a condition for their approval and release.

Input to and output from the computer and related systems offormulas are not checked for accuracy.

An NDA-Field Alert Report was not submitted within three working days of re~ipt ofinformation concerning significant chemical, physical, or other change or deterioration in a distributed drug product Specifically, all complainants finished drug product samples received at your firm and acknowledged to be intact as well as your positive identification ofparticulate matter during annual reserve sample examination.

Procedures for the preparation ofmaster production and control records are not followed.

Records of returned drug products are not maintained.

Buildings used in the manufacture, processing, packing or holding ofdrug products are not free ofinfestation by rodents, birds insects, and other vennin.

Deviations from written production and process control procedures are not justified.

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

Verification ofthe suitability ofthe testing methods is deficient in that they are not performed under actual conditions ofuse.

Equipment used in the manufacture, processing, packing or holding ofdrug products is not suitably located to facilitate operations for its intended use.

Drug product container and closure test procedures are deficient in that containers are not tested for confonnance in accordance with appropriate written procedures.

Master production and control records lack complete manufacturing and control instructions, special notations, a nd precau stions to b e follow ed.