F.H. Investments Inc dba Asteria Health — FDA 483 Findings

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

Each batch of controlled-release dosage form drug product is not laboratory tested to determine conformance to the specifications for the rate of release for each active ingredient.

Aseptic processing areas are deficient in that wall are not smooth and/or hard surfaces that are easily cleanable.

The batch production and control records are deficient in that they do not include documentation of the accomplishment of each significant step in manufacturing, and processing.

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

Laboratory records do not include complete data derived from all tests, examinations and assay necessary to assure compliance with established specifications and standards.

Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include adequate validation of the sterilization process.

Appropriate controls are not exercised over computers or related systems to assure that changes in master production and control records or other records are instituted only by authorized personnel.

Drug products do not bear an expiration date determined by appropriate stability data to assure they meet applicable standards of identity, strength, quality and purity at the time of use.

The quality control unit lacks authority to review production records to assure that no errors have occurred and folly investigate en ors that have occurred.