Baxa Corporation – FDA Warning Letter, Jul 30, 2007

An FDA inspection of Baxa Corporation in Englewood, Colorado, from July 12-30, 2007, revealed that the firm's electro-mechanical infusion pumps, pharmacy compounders, and related equipment are adulterated. The manufacturing, packing, storage, or installation methods and controls do not conform to Current Good Manufacturing Practice (CGMP) requirements of the Quality System (QS) regulation (21 CFR Part 820).

Violations include: 1. Failure to follow design control procedures for design changes (21 CFR 820.30(i)), exemplified by the unapproved Exacta-Mix 2400 (EM2400) Operating Software change, leading to a recall. 2. Failure to adequately validate design changes by not establishing acceptance criteria prior to validation activities (21 CFR 820.30(g)). 3. Failure to establish and maintain CAPA procedures to prevent recurrence of nonconforming products (21 CFR 820.100(a)(3)), as seen with unaddressed distributed EM2400 units despite identified issues. 4. Failure to investigate all complaints involving possible device specification failures (21 CFR 820.198(c)), with insufficient documentation for "customer error" or "normal wear and tear" determinations. 5. Failure to evaluate complaints for Medical Device Reporting (MDR) requirements (