Foundation Care LLC – FDA 483, Mar 19, 2013

The FDA Form 483 details numerous deficiencies at a sterile drug product manufacturing facility. Key issues include inadequate procedures to prevent microbiological contamination. The media fill procedure and documentation are insufficient, lacking details on processing times, intervention types/numbers, and maximum personnel in the ISO 5 cleanroom during dynamic operations.

Environmental monitoring is deficient; SOP 8B.16 fails to include daily dynamic monitoring for the ISO 5 cleanroom and omits equipment like BAXA pumps and chairs from monthly monitoring. Daily personnel monitoring is not performed, with annual monitoring only. A smoke study procedure for the ISO 5 cleanroom under dynamic conditions is absent, and no studies have been conducted since 2005, or after a 2007 air handling unit installation.

Aseptic cleaning practices are not consistently followed (e.g., overlapping strokes, top-to-bottom). Glove change frequency is undefined, and employees were observed not changing gloves after contamination. Aseptic technique breaches include leaving the cleanroom/anteroom door open and employees failing to follow handwashing procedures (e.g., rinsing from fingertips to elbows). The anteroom lacks a clock for handwashing timing. Exposed skin around the neck and face was observed due to inadequate gowning (non-sterile surgical gowns, home-laundered scrubs, non-sterile bouffant caps, masks, shoe covers).

Product testing is insufficient; potency testing is not routine (e.g.,