Central Admixture Pharmacy Services, Inc. (CAPS) — FDA 483 Findings

The firm's Quality Unit failed to identify, investigate, and implement permanent corrective actions after events that could impact the quality, safety, efficacy, and purity of sterile injectable drug products manufactured whether or not the batches has been already distributed.

The sterile technique qualification (media fills) do not represent routine operating conditions and does not evaluate worst-case activities that can provide a challenge to manual aseptic operations.

Gowning used to manufacture sterile drug products is inadequate: a.

The firm performs numerous manual aseptic manipulations in the filling of sterile injectable drug products intended for patient use.

The firm's Quality Unit failed to evaluate and perform a risk assessment and implement applicable corrective actions for approximately 17 supplier recall notifications received January-September 2012.

The investigation into the two sterility failures did not assess for possible root causes of the contamination.

There is a lack of microbial reduction/control steps in the manufacturing process of sterile drug products.

The firm's practices for microbial identification do not provide information related to the microbiological populations found in manufacturing areas where sterile drug products are manufactured.

The firm failed to exclude the ingress of pests into the facility as follows: a.

The firm does not test the potency of the final drug product after numerous lots are further diluted as pan of the manufacturing process of sterile drug products for patient use.

There is no scientific justification for the selections and frequencies of the environmental monitoring sampling locations currently used at the firm's controlled areas (ISO 5, ISO 7 and ISO 8) where sterile drug products are manufactured.

The firm applies expiration dating to all compounded sterile injectable products.

The firm's cleaning procedures and practices are inadequate to control microbial population in the controlled areas used to manufacture sterile drug products.

Air Flow pattern studies "smoke studies" are inadequate for the following reasons: a.