FDA 483 - STAQ Pharma, Inc. - September 29, 2021

On September 29, 2021, the FDA issued a Form 483 to STAQ Pharma, Inc., an outsourcing facility located at 14135 E 42nd Avenue, Suite 50, Denver, CO 80239-5214, following an inspection conducted from September 20-24 and 27-29, 2021. The inspection identified three observations.

Observation 1 noted that procedures to prevent microbiological contamination of sterile drug products lacked adequate aseptic process validation. Specifically, the ISO 5 Laminar Flow Hood (LFH) and ISO 7 Room were not recertified after the LFH was moved on September 17, 2020, yet the firm continued producing aseptically filled syringes. Additionally, nonviable and viable air samplers inside the ISO 5 LFH were not operational during a dynamic smoke study on September 17, 2020.

Observation 2 indicated deficiencies in the environmental monitoring system for aseptic processing areas. Environmental monitoring was absent for ancillary equipment within the ISO 5 LFH, including non-viable and viable hoses, a power cord from a pump to an electrical outlet, protruding screw caps, an IV hanging bar and hooks, and an L-shaped bar supporting the fill bag.

Observation 3 stated that the outsourcing facility failed to submit required product reports to the FDA for compounded