Eosera, Inc. — FDA 483 Findings

Written procedures are not established for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding of a drug product.

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

Failure to reject any lot of drug product containers that did not meet the appropriate written specifications for identity, strength, quality, and purity.

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

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

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

Your firm failed to establish adequate written procedures for production and process controls designed to assure that the drug products have the identity, strength, purity, and quality that they are purported or represented to possess.

Each component is not tested for conformity with all appropriate written specifications for purity, strength, and quality.

Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design to facilitate operations for its intended use.