Caraco Pharmaceutical Laboratories, Ltd. — FDA 483 Findings

The building lacks adequate space for the orderly placement of equipment and materials to prevent mix-ups between different components and in-process materials and to prevent contamination, Specifically, Raw material warehouse facility did not have adequate storage available for all of its raw materials and in-process materials.

Records are not maintained so that data therein can be reviewed at least annually to evaluate the quality standards of each drug product to determine tile need for changes in specifications or manufacturing or control procedures.

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

Written procedures are not followed for the storage and handling of components.

Procedures are not established which are designed to assure that the responsible officials of the finn, if they are not personally involved in or immediately aware of such actions, are notified in writing of investigations conducted.

Individuals responsible for supervising the processing of a drug product lack the training and experience to perform their assigned functions in such a manner as to assure the drug product has the safety, identity, strength, quality and purity that it purports or is represented to possess.

Written production and process control procedures are not followed in the execution of production and process control A.

There is a failure to thoroughly review any unexplained discrepancy whether or not the batch has been already distributed.

Records fail to include an individual inventory record of each reconciliation of the use of each component with sufficient information to allow determination of any associated batch or lot of drug product.

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

Written records of investigation of a drug complaint do not include the findings of the investigation and the follow-up.

Time limits are not established when appropriate for the completion of each production phase to assure the quality of the drug specified.

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

Batch production and control records do not include the weights and measures of components used in the course of processing each batch of drug product produced.