Exela Pharma Sciences LLC – FDA 483, Sep 28, 2017

The FDA Form 483 details multiple deficiencies at an unnamed facility. Key issues include inadequate handling and storage of components and drug product containers, leading to potential contamination. The firm cannot ensure materials, products, and samples are kept at controlled room temperature, particularly during transport between facilities via non-temperature-controlled company trucks and employees' personal vehicles. Samples transported in Ziploc bags lack seals and proper documentation of transport time.

Microbiology samples are not maintained at controlled room temperature, with the lab exceeding upper temperature limits in March, April, May, and July 2017. Aseptic processing areas lack adequate environmental monitoring, and ISO-classified areas were not certified under dynamic conditions for Sodium Bicarbonate Injection lots. Pressure differentials in ISO 5 areas are not monitored during production.

Electronic equipment is not routinely checked, and the system verifying lot numbers/expiration dates and barcodes is not challenged to detect incorrect information. Results of packaged and labeled product examinations are not documented. Labeling operations lack strict control, and the electronic label creation system, "NiceLabel," is not validated. PDF labels were stored on an unsecure network drive, and access permissions were altered during the inspection. The firm also lacks a defined maximum timeframe for labels in the non-temperature-controlled QA Office/Staging Area. Additionally, the drug product labels themselves are deficient.