Isomeric Pharmacy Solutions LLC — FDA 483 Findings

Procedures describing the handling of all written and oral complaints regarding a drug product are not f ollowed, Specifically, Since the previous inspection, your firm has documented 33 customer complaints and none have been i nvestigated.

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

Written procedures are not established and followed for the cleaning and maintenance of equipment, including utensils, used in the manufacture, processing, packing or holding o f a drug product.

The separate or defined areas and control systems necessary to prevent contamination or mix-ups are def icient.

An adequate number of batches of each drug product are not tested to determine an appropriate expiration date.

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

Written records of investigations into unexplained discrepancies and the failure of a batch or any of its components to meet specifications do not always include the conclusions and the follow-up.

There are no written procedures for production and process controls designed to assure that the drug products have the identity, strength, quality, and purity they purport or are represented to possess.

Employees are not given training in the particular operations they perform as part of their function, cu rrent good manufacturing practices and written procedures required by current good manufacturing pr actice regulations.

Deviations from written production and process control procedures are not recorded and justified.

OE.PARTMENT OF HEALTH AND HUMAN SERVICES FOOD AND DRUG ADMfNISTRATION DISTRICT ADDRESS AND PHONE NUM8ER 6th & Kipling St .

Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design to facilitate operations for its intended use and cleaning and maintenance.

Routine calibration of automatic and electronic equipment is not performed according to a written program designed to assure proper performance.

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