BSO, LLC — FDA 483 Findings

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.

Employees engaged in the manufacture and processing of a drug product lack the training required to perform their assigned functions.

Reserve samples from representative sample lots or batches of drug products selected by acceptable statistical procedures are not examined visually at least once a year for evidence of deterioration.

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

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

The written stability program for drug products does not include specific test methods.

The written stability program does not assure testing of the drug product in the same container-closure system as that in which the drug product is marketed.