FDA 483 - SCA Pharmaceuticals, Inc. - April 01, 2014

On March 17, 2014, to April 1, 2014, an FDA inspection was conducted at SCA Pharmaceuticals, LLC, an outsourcing facility located at 8821 Knoedl Court, Little Rock, AR 72205-4600. The inspection identified several deficiencies.

**Observation 1: Unclean and Insanitary Buildings** The facility's ISO 5 Laminar Flow Hoods (16E and 16F), used for sterile injectable drug production, were found with multiple white residue splatters on the HEPA filter grates. In Hood 16E, splatters measured approximately 4x3 inches and 8x8 inches, while Hood 16F had splatters of approximately 4x6 inches. Cefazolin and another drug product were being compounded during the observation.

**Observation 2: Deficient Aseptic Processing Area Equipment Maintenance** HEPA filters in ISO 7 and ISO 8 clean rooms were not leak tested during the last two ISO certification inspections (May 1, 2013, and November 25, 2013). Magnehelic differential pressure gauges for ISO 7 and ISO 8 clean rooms had never been calibrated, and Room B (ISO 7) lacked a pressure gauge. Daily pressure excursions in the ISO 7 room from December 13,