Caraco Pharmaceutical Laboratories, Ltd. — FDA 483 Findings

For components removed from the original containers, the new container fails to be identified with receiving or control number.

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.

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

Procedures for the cleaning and maintenance of equipment are deficient regarding sufficient detail of the methods, equipment, and materials used in the cleaning and maintenance operation, and the methods of disassembly and reassembling equipment as necessary to assure proper cleaning and maintenance.

Employees engaged in the manufacture and processing of a drug product lack the training required to perform their assigned functions.

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.

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

Batch production and control records do not include complete information relating to the production and control of each batch.

Equipment and utensils are not cleaned and maintained at appropriate intervals to prevent malfunctions and contamination that would alter the safety, identity, strength, quality or purity of the drug product.

Written production and process control procedures are not documented at the time of performance.

Procedures describing the warehousing of drug products are not established.

Component weighing, measuring, and subdividing operations are not adequately supervised.

GMP training is not conducted on a continuing basis and with sufficient frequency to assure that employees remain familiar with CGMP requirements applicable to them.

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