Barclay, Luke, Pillai Specialty Pharmacy, PLLC — FDA 483 Findings

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

Testing and release of drug product for distribution do not include appropriate laboratory dete1mination o f satisfactory conformance to the final specifications and identity and strength of each active ingredient p rior to release.

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 disti-ibuted.

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

Clothing of personnel engaged in the of diug products is not appropriate for the duties they perfo1m .

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 diug product.

You did not have a HEP A filter over the area to which sterile product was exposed.

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

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

Batch production and control records are not prepared for each batch of drug product produced and do not include complete information relating to the production and control of each batch.