Custom Compounding Centers, LLC – FDA 483, Aug 28, 2014

This FDA Form 483 was issued to Custom Compounding Centers, LLC, a producer of sterile drug products located at 10525 Humbolt Street, Los Alamitos, CA 90720. The inspection, conducted from August 4 to August 28, 2014, by Investigator Joey V. Quitania, identified three observations.

Observation 1 noted deficiencies in the environmental monitoring system for aseptic processing areas. Specifically, there was a lack of active monitoring of differential pressures between the ISO 5 and ISO 7 cleanroom areas, which are separated only by flexible plastic curtain strips, and no system to detect loss of air supply to HEPA filters during processing. Additionally, there was no active non-viable particulate air monitoring in the ISO 5 and ISO 7 areas during aseptic processing, with only semi-annual monitoring by an outside contractor.

Observation 2 stated that each batch of drug product required to be free of objectionable microorganisms was not tested through appropriate laboratory testing. The firm did not perform release testing to assess the presence of bacterial endotoxin in finished drug products that were aseptically processed and not terminally sterilized, despite being produced from non-sterile API and sterilized by 0.22µ filtration.

Observation 3 indicated that testing and release of drug product for distribution did not include appropriate laboratory determination of satisfactory conformance to the identity and strength of each active ingredient prior to release. The firm did not conduct