DCA Inc. dba Beacon Prescriptions — FDA 483 Findings

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

The flow of components, drug product containers, in process material and drug product through the building is not designed to prevent contamination.

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

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

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

The calibration ofinstruments is not done at suitable intervals in accordance with an established written program and with provisions for remedial action in the event accuracy and/or precision limits arc not met.

Employees engaged in the manufacture, processing and packaging of drug product lack the training required to perform their job functions.