55 of 58 inspected 503B facilities received a Form 483

55 of 58 outsourcing facilities with an inspection date on the FDA's 503B register had a Form 483 issued following that inspection, as of 2026-07-28. A Form 483 lists what an investigator observed; it records observations, not a final agency determination. The rate says less about any one facility than about the register as a whole: when the FDA does inspect, it nearly always finds something to document.

FDA registered outsourcing facilities · The 503B register, with inspection and enforcement status · data effective Jul 28, 2026