Right Value Drug Stores, LLC dba Carie Boyd's Prescription Shop — FDA 483 Findings

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

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

The container labels of your outsourcing facility's drug products are deficient.

Batch production and control records do not include dates of each significant step in the manufacture and processing of the batch for each batch of drug product produced.

Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the aseptic and sterilization process.

Written procedures are lacking which describe in sufficient detail the receipt, identification, sampling, testing, approval and rejection of components.

Your outsourcing facility did not submit a report to FDA identifying the drugs compounded during the previous six month period.

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.

Drug product closures were not clean and sterilized and processed to remove pyrogenic properties to assure that they are suitable for their intended use.