Care-Tech Labs, Inc — FDA 483 Findings

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, Specifically,

Adequate lighting is not provided in 'all areas.

Investigations of an unexplained discrepancy and a failure ofa batch or any of its components to meet any ofits specifications did not extend to other batches ofthe same drug product and other drug products that may have been associated with the specific failure or discrepancy.

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.

Laboratory controls do not include the establishment ofscientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that in-process materials and drug products confonn to appropriate standards ofidentity, strength.

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

Deviations from written prod~ction and process control procedures are not justified.

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

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

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

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

Drug products failing to meet established specifications are not rejected.

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.

Batch production and control records do not include the identification of the persons checking each significant step in the operation, for each batch of drug product produced.

Equipment and utensils are not cleaned, maintained.

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

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

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 for the cleaning and maintenance ofequipment, including utensils, used in the manufacture, processing, packing or holding ofa drug product.

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

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 that describe the in-process controls, tests, and examinations to be conducted on appropriate samples of in-process materials of each batch.

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.