Aurolife Pharma LLC — FDA 483 Findings

Control procedures are not established which validate the performance ofthose manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product.

Buildings used in the manufacture, processing, packing or holding of drug products are not maintained in a clean and sanitary condition and are free of infestation by insects and other vermin.

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

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

In-process samples are not representative.

Procedures for corrective and preventive action have not been adequately established.

Testing and release ofdrug product for distribution do not include appropriate laboratory determination of satisfactory conformance to the final specifications prior to release.

Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to assure that components and drug products conform to appropriate standards of identity, strength, quality and purity.

Routine calibration of automatic equipment is not performed according to a written program designed to assure proper performance.

11 (bTC"'f ield Alert Report was not submitted within three working days of receipt of information concerning a failure ot one or more distributed batches of a drug to meet the specifications established for it in the application.