FDA 483 - lincare, inc. - June 12, 2015

The FDA Form 483 inspection revealed significant deficiencies in aseptic processing, environmental monitoring, and facility control. The ISO 8 Ante Room was out of certification from April 9, 2015, yet approximately (b)(4) sterile products were produced in ISO 7 Buffer Rooms at ISO 5 Hoods between April 9 and May 29, 2015. Pressure differentials were consistently out of acceptable range, with the ISO 7 Hazard Room showing "0" pressure from January 2, 2014, to May 29, 2015, despite a required minimum of -(b)(4) inches of water. Pressure gauges for critical room differentials were not calibrated, nor was the incubator for environmental monitoring samples.

Facility issues included a difficult-to-clean, damaged chair in an ISO 7 Buffer Room, an ISO 5 hood on a wooden table, and corroded, difficult-to-clean ISO 5 hoods. Personnel gowning was inadequate, with technicians observed wearing non-sterile attire and exposing skin, and cleaning practices were deficient, including touching contaminated surfaces and re-entering clean areas without sanitizing gloves. Unsanitized items were brought into the ISO 8 area, and reusable cleaning tools were moved between rooms without sanitization.

Pest infestations were observed in the ISO 8 area, including a live worm-like pest, a live spider, and dead insects in a refrigerator holding