Isomeric Pharmacy Solutions LLC — FDA 483 Findings

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 current good manufacturing practice regulations.

Written records of investigations into unexplained discrepancies and the failure of a batch or any of its components to meet specifications do not include the conclusions and follow-up.

Procedures designed to prevent microbiological contamination of drug products purporting to be sterile do not include validation of the sterilization process.

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

Deviations from written production and process control procedures are not justified.

Time limits are not established when appropriate for the completion of each production phase to assure the quality of the drug product.

Separate or defined areas to prevent contamination or mix-ups are deficient regarding operations related to aseptic processing of drug products.

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

An adequate number of batches of each drug product are not tested to determine an appropriate expiration date.