FDA 483 - California Pharmacy & Compounding Center - April 21, 2017

The FDA Form 483 details multiple observations from an inspection conducted at a pharmaceutical facility. The firm failed to protect against insect infestation, evidenced by 23 environmental monitoring deviations with fly larvae contamination in the incubator from 2/26/2016 to 10/10/2016, and dead insects observed in glue traps in the ISO-8 room.

Several structural and material deficiencies were noted. The ISO-5 classified hood's horizontal working surface is laminated particle board, not easily cleanable, with separating edges and exposed particle board underside, risking microbial harborage. Cabinets, a scale's wooden box, and a wooden stool in the ISO-8 room are also made of porous, difficult-to-clean particle board or wood. Particle board dust was observed.

Facility design issues include return vents in the ISO-8 room ceiling located next to HEPA filters, perforations in the ISO-7 room ceiling allowing unfiltered air entry, peeling caulking around a camera wire hole, and taped thermostat wiring. The ISO-8 room entrance has carpet and broken linoleum. An unused plywood door to a non-classified space, sealed with painter's tape, and shedding drywall with a hole were also observed.

Operational and quality control issues include the use of non-sterile containers refilled with sterile solutions in the ISO-7 room, with no assurance of sterility maintenance. A dirty area with stains, gloves, dust,