FDA 483 - I.V. Specialty, Ltd - July 28, 2017

This FDA Form 483 documents observations from an inspection, highlighting deficiencies in facility maintenance, aseptic practices, and cleaning/sanitizing procedures for sterile drug processing.

**Facility and Operations:** The facility processes sterile drugs within an ISO 7 clean room and an ISO 5 laminar air flow (LAF) hood. An ante room is intended to meet ISO 8 standards.

**Violations and Observations:** * **Vermin:** Vermin was observed adjacent to the production area. A dead spider was found in a HEPA filter in the ISO 7 clean room, near the ISO 5 LAF hood. * **Clean Room Surfaces and Equipment:** * ISO-classified areas contained difficult-to-clean, particle-generating, or visibly dirty equipment/surfaces. * LAF Hood (b)(4) had loose panels above the aseptic processing area. * LAF Hood (b)(4) had a loose access panel below the processing table. * Dirt, debris, stains, and a 2-inch hair were observed in the front recirculation vent of the ISO 5 hood. * LAF Hood (b)(4) was on a multi-surface (wood fiber board, stainless steel, painted, formica) table, making it difficult to sanitize. * An office-style telephone with wiring on the floor created a difficult-to-sanitize