Coastal Meds, LLC — FDA 483 Findings

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

Protective apparel is not worn as necessary to protect drug products from contamination.

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

There is a failure to thoroughly review the failure of a batch or any of its components to meet any of its specifications whether or not the batch has already been distributed.

Each lot of drug product containers and closures is not withheld from use until the lot has been sampled, tested, examined, and released by the quality control unit.

Drug products do not bear an expiration date determined by appropriate stability data to assure they meet applicable standards of identity, strength, quality and purity at the time of use.

Aseptic processing areas are deficient regarding systems for maintaining any equipment used to control the aseptic conditions.

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

The labels of your outsou rcing facility's drug products are deficient.

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