PCP LV LLC dba Pinnacle Compounding Pharmacy — FDA 483 Findings

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

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

Clothing of personnel engaged in the manufacturing and processing of drug products is not appropriate for the duties they perform.

The responsibilities and procedures applicable to the quality control unit are not in writing.

The labels of your outsourcing facility's drug products do not include information required by section 503B(a)(10)(A) and Anh Lac, I nvestigator ~~

Each batch of drug product purporting to be sterile and pyrogen-free is not laboratory tested to determine conformance to Each batch of drug product purporting to be sterile and pyrogen-free is not laboratory tested to determine conformance to Specifically, finished product certificates of analysis from your contract laboratory reference Sterility and Bacterial Endotoxin USP <85> tests.

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

Aseptic processing areas are deficient regarding air supply that is filtered through high-efficiency particulate air filters under positive pressure.

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

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 been already distributed.