Lowlyn Pharmacies, Inc — FDA 483 Findings

Testing and release of drug product for distribution do aot include appropriate laboratory determination of satisfactory conformance to the tinai specifications and identity and strength of each active mgredient prior to release.

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

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

The flow of drug product containers, closures, in-process materials, and drug products though the building is sot designed to prevent contamination.

Drug product containers and closures were not clean and sterilized and processed to remove pyrogenic properties 10 assure that they are suitabie Tor their intended uss.

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

Each batch ofdrug product required to be free of objectionable microorganisms is not tested through appropriate laboratory ‘testing.