Care-Tech Labs Inc. — FDA 483 Findings

Specificall according to management from approximately 11114/2007 to 212112008 the finn had numerous problems with the HPLC instrumentation.

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

operation, for each batch of drug product produced.

Batch production and control records do not include complete inforination relating to the production and control ofeach batch.

Equipment and utensils are not cleaned, maintained.

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.

Testing and release of drug product for distribution do not include appropriate laboratory detennination ofsatisfactory conformance to the final specifications and identity and strength ofeach active ingredient prior to release.

Accelerated stability studies, combined with basic stability infonnation, used to support tentative expiration dates are not supported with ongoing full shelf life studies.

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

Written procedures are not established and followed for evaluations done at least annually and including provisions for a review ofreturned or salvaged drug products and investigations conducted for each drug product.

Changes to written procedures are not drafted, reviewed and approved by the appropriate organizational unit and reviewed and approved by the quality control unit.

Written records are not always made of investigations into unexplained discrepancies and the failure ofa batch or any of its components to meet specifications.

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

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 distnbuted.

Specific identification tests are not conducted on components that have been accepted based on the supplier's report of analysis.

Adequate lighting is not provided in 'all areas.

Reprocessing procedures lack the steps to be taken to insure that reprocessed batches will conform with all established standards, specifications, and characteristics.

The quality control unit lacks the responsibility and authority to approve and reject all components, drug product containers, closures, in process materials, packaging material, labeling, and drug products.

Written procedures are not established and followed that describe the in-process controls, tests, and examinations to be conducted on appropriate samples of in-process materials of each batch.