FDA 483 - Curexa - East, LLC dba Curexa - October 09, 2020

During an FDA inspection, non-microbial contamination was observed in the production area. On August 26, 2020, a pervasive fine blue dust/residue, generated from tadalafil and sildenafil production, coated the tableting room's walls, ceiling, vents, blender lid, humidifier, and air conditioner. Darker accumulations were noted on stationary blender wheels. This blue residue infiltrated other production areas, including the Non-Hazardous and Hazardous Rooms, observed within unsealed transfer holes leading to the Hazardous Room, despite products compounded there not containing blue coloring. On September 1, 2020, the room was reported clean, but the blue residue persisted in the humidifier and on other surfaces.

Additionally, a failing potency result for a hormone sample was identified. On September 1, 2020, a contract testing laboratory confirmed a potency of 89.6% for a stock drug (specification: (b)(4)), which was used in approximately nine other drug products. A corrective action document dated July 8, 2020, was provided, predating the initial failure notification of July 14, 2020. The pharmacist-in-charge confirmed no corrective action was conducted for drugs produced on August 12, 2020, using the failing stock. Furthermore, a record for (b)(4) lacked an ingredient weight, with no deviation or investigation, violating