FDA 483 - Pine Pharmacy and Home Care Products Center, Inc. - December 16, 2013

The FDA Form 483 details multiple deficiencies at a drug manufacturing facility. The cleanroom's design is inadequate, lacking sufficient environmental monitoring data to confirm ISO 5 (Class 100) conditions at the laminar flow hood (LAFW) and biological safety cabinet (BSC), and ISO 7 (Class 10,000) conditions in the buffer, gowning, and storage rooms. Smoke studies were not performed under actual processing conditions to verify unidirectional airflow.

Personnel clothing is inappropriate for sterile drug product processing; operators wear non-sterile gowns, glasses/goggles, footwear, and facial masks, with only gloves being sterile. Their faces and heads are not fully enclosed, exposing skin and hair over critical ISO 5 areas.

Procedures to prevent microbiological contamination are not established. Environmental monitoring for viable air counts in the ISO 5 zone is performed infrequently by an outside contractor, as is non-viable particulate monitoring. Work surfaces inside ISO 5 hoods are not frequently tested for microbial contamination.

Separate facilities are lacking to prevent contamination from beta-Lactam non-penicillin drugs, which are processed in the same ISO 5 hoods as non-beta-Lactam drugs, raising concerns about cross-contamination. Equipment and utensils are not sanitized at appropriate intervals; non-sterile wipes are used with disinfectant.

Laboratory controls are deficient. Assay or product identification testing, sterility testing (except for specific cases like Avastin), and endot