FDA ·
A Form 483 is issued at the conclusion of an FDA inspection when investigators identify conditions that may constitute violations of the FDCA. It lists specific observations and typically requests a formal written response within 15 business days. Form 483s are not themselves enforcement actions but often precede warning letters or more serious measures. Throughout 2025 and 2026 FDA investigators have issued Form 483s to numerous compounding pharmacies producing GLP-1 peptides, citing observations ranging from inadequate stability testing to questionable API supplier qualifications. Publicly available 483s provide a valuable window into FDA's evolving quality expectations.
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