Central Admixture Pharmacy Services, Inc. — FDA 483 Findings

Drug product production and control records, are not reviewed and approved by the quality control unit to determine compliance with all established, approved written procedures before a batch is released or distributed.

Buildings used in the manufacture, processing, packing or holding of drug products are not maintained in a clean and sanitary condition and free of infestation by rodents, birds insects, and other vermin.

The responsibilities and procedures applicable to the quality control unit are not in writing and fully followed.

Results of stability testing are not used in determining expiration dates.

The accuracy, sensitivity, specificity and reproducibility of test methods have not been established and documented.

Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not followed.

Aseptic processing areas are deficient regarding systems for maintaining any equipment used to control the aseptic conditions.

Input to and output from the computer, related systems of formulas and records or data are not checked for accuracy.

Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.

Samples taken of drug products for determination of conformance to written specifications are not properly identified.

The calibration of instruments, apparatus and recording devices 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 are not met.

Your firm failed to establish 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.

Batch production and control records are not prepared for each batch of drug product produced and do not include complete information relating to the production and control of each batch.

Procedures designed to assure that correct labels are used for drug products are not followed.

Written production and process control procedures are not followed in the execution of production and process control functions and documented at the time of performance.

Adverse drug experience information has not been reported to FDA.

related to Rocuronium method validation concerns.

related to repeated Rocuronium failures and subsequent retesting.

There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed.