Cantrell Drug Company — FDA 483 Findings

Drug product containers and closures were not clean to assure that they are suitable for their intended use.

Employees are not given training in the particular operations they perform as part of their function.

Procedures describing the handling of written and oral complaints related to drug products are deficiently written or followed.

Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality and purity.

The identity of each component of a drug product is not verified by conducting at least one test to verify the identity, using specific identity tests if they exist.

Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established.

Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the equipment to produce aseptic conditions.

Buildings used in the manufacture, processing, packing, or holding of a drug product do not have the suitable construction to facilitate cleaning, maintenance, and proper operations.

There is no written testing program designed to assess the stability characteristics of drug products.

Aseptic processing areas are deficient regarding the system for monitoring environmental conditions.

Approved drug product containers and closures are not retested or reexamined as appropriate for identity, strength, quality and purity after exposure to conditions that might have an adverse effect with subsequent approval or rejection by the quality control unit.