Ameridose, LLC — FDA 483 Findings

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

Buildings used in the manufacture, processing, packing, or holding ofa drug product do not have the suitable to facilitate cleaning, maintenance, and proper operations.

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 of the drug product.

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

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

Equipment for adequate control over air pressure is not provided when appropriate for the manufacture, processing, packing or holding ofa drug product.

The accuracy, sensitivity, specificity, and reproducibility of test methods have not been established and documented.

Testing and release ofdrug product for distribution do not include appropriate laboratory determination ofsatisfactory conformance to the identity and strength ofeach active ingredient prior to release.

There are no written procedures for production and process controls designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess.

Procedures describing the handling ofwritten and oral complaints related to drug products are deficiently written or followed.

Written complaint records do not include, where known, nature ofcomplaint.

The operations relating to the manufacture, processing, and packing ofpenicillin are not performed in facilities separate from those used for other drug products for human use.

Each batch ofdrug product purporting to be sterile is not laboratory tested to determine conformance to such requirements.

Buildings used in the manufacturing, processing, packing, and holding ofa drug product are not maintained in a good state of repair.

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