FDA 483 - Fagron Compounding Services - March 24, 2022

An FDA inspection of Fagron Compounding Services, an outsourcing facility located at 8710 E 34th St N, Wichita, KS, was conducted from March 1 to March 24, 2022. The inspection identified six observations regarding deficient practices.

Observation 1 noted deficiencies in cleaning and disinfecting aseptic processing areas. Specific instances included the failure to clean the inside back of an ISO 5 Horizontal laminar flow hood prior to producing Moxifloxacin Lot # (b)(4) and Norepinephrine Bitartrate 32 mcg/mL Lot # (b)(4). Additionally, parts of an ISO 7 Cleanroom (Fill room (b)(4)), including a wall protrusion, areas around an ISO 5 hood, and the floor under a pump cart, were not cleaned.

Observation 2 highlighted the absence of written procedures for production and process controls to ensure drug product identity, strength, quality, and purity. This included a lack of equipment qualification for a (b)(4) transferred in January 2020, used for Sodium Thiosulfate 25% production. The master batch record for Sodium Thiosulfate 25% solution did not record the asset number for the (b)(4) used, and the SOP for the (b)(4) lacked a program for (b)(4) to (b)(4), impacting approximately (b)(4) batches of Sodium Thiosulfate 2