FDA 483 - Central Admixture Pharmacy Services, Inc. - January 19, 2007

The FDA Form 483 inspection revealed multiple deficiencies at the facility. The quality control unit lacks authority for critical tasks like raw material and finished product release, which are handled by (b)(4) per SOP #A0201. This led to the release of mislabeled Oxytocin (500ml Dextrose 5% Lactated Ringers labeled as 1000ml Lactated Ringers) without QC review.

Product complaint file reviews showed the firm failed to follow SOP #F0400 regarding labeling verification, resulting in three mislabeled product lots since September 2005. The firm also violated SOP #E0200 by misidentifying 5% dextrose solution as citrate phosphate dextrose, leading to its incorrect use in Cardioplegia formulations.

Batch records are incomplete, only listing lot numbers for WSAM/MSG and Tromethamine. Sterility testing is not performed on every finished injectable drug product batch, only on a (b)(4) basis. There is no SOP for corrective actions/investigations for out-of-specification active ingredients.

Mannitol storage temperatures frequently exceeded the firm's own specifications (b)(4) degrees C, with 135 instances noted, and the firm has not validated its specification. Environmental monitoring for (b)(4) also showed 44 out-of-specification temperature instances. Environmental monitoring testing lacks positive controls for media.

The firm uses