FDA 483 - Central Admixture Pharmacy Services, Inc. - May 24, 2021

This FDA Form 483 document details observations from an inspection, highlighting deficiencies in aseptic processing and environmental control. The facility failed to adequately evaluate products or take remedial action following actionable microbial contamination in the ISO 5 classified aseptic processing area. Specifically, viable surface samples from the laminar flow hood (ISO 5) showed at least 1 cfu on July 31, 2019, August 7, 2019, February 19, 2020, and May 27, 2020. Additionally, employee fingertip testing yielded positive results on November 18, 2019, November 4, 2020, and November 7, 2020, without subsequent product evaluation or remedial action beyond (b)(4) cleaning.

Disinfectant contact time and coverage were insufficient; during May 6, 2021, cleaning, the (b)(4) solution's recommended dwell time of (b)(4) was not met for ISO 5 LFH, carts, and other items, with immediate wiping reducing contact time to (b)(4). Carts used for material introduction also did not receive the recommended (b)(4) contact time for (b)(4).

Personnel aseptic technique was compromised. On May 3, 2021, employees touched surfaces outside the ISO 5 area with gloved hands, then