Brands International Corporation — FDA 483 Findings

The written stability testing program is not followed.

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

Reserve samples from representative sample lots or batches of drug products selected by acceptable statistical procedures are not examined visually at least once a year for evidence of deterioration.

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

Each batch ofdrug product required to be free of objectionable microorganisms is not tested through appropriate laboratory testing.

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 the need for changes in specifications or manufacturing or control procedures.

Procedures for the cleaning and maintenance ofequipment 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.

There is a failure to handle and store components, drug product containers, and closures at all times in a manner to prevent contamination.

Employees are not given training in the particular operations they perform as part of their function, current good manufacturing practices, and written procedures required by good manufacturing regulations.

Your firm failed to have, for each batch of drug product, appropriate laboratory determination of satisfactory conformance to final specifications for the drug product, including the identity and strength of each active ingredient, prior to release.

Written procedures describing the handling ofcomplaints do not include provisions 'for review by the quality control unit of any complaint involving the possible failure of a drug product to meet any of its specifications and a determination as to the need for an investigation of any unexplained discrepancy.

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.

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

Procedures designed to assure conformance to written specifications do not require appropriate retesting of components, drug product containers, and closures subject to deterioration.

The building lacks adequate space for the orderly placement of equipment and materials to prevent mix-ups between different components, drug product containers, closures, and drug products and to prevent contamination.

Representative samples are not taken of each shipment of each lot of drug product containers for testing or examination.

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

Established laboratory control mechanisms are not documented at the time of performance.

Individuals responsible for supervising the manufacture, processing, packing, or holding of a drug product lack the education, 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.