FDAnews Drug Daily Bulletin
Pharmaceuticals / Quality / Inspections and Audits

Cleanroom Problems Found in Compounder Inspection

June 7, 2017

FDA inspectors found extensive cleanliness and sterility issues during visits to California Pharmacy and Compounding Center in Newport Beach, Calif., in March and April.

During the visits, inspectors observed glue traps in an ISO-8 cleanroom with “what appeared to be dead insects inside the traps.”

Between Feb. 26, 2016, and Oct. 10, 2016, the compounder’s incubator reportedly had 23 environmental monitoring samples contaminated with fly larvae.

Inspectors also found deficiencies in cleanliness and sterility at the outsourcing facility, including latex gloves, dust and dead insects on the floor of what are meant to be aseptic processing areas.

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