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FDA inspection records of major CDMOs

Contract manufacturers make drugs for many companies at once, so one plant's inspection can matter to several. Here is what FDA's records show for 30 of them, site by site.

By Kevin Koshy, Founder, SourcebrookPublished 23 Sep 2026Updated 23 Sep 2026

Why a CDMO's inspection record matters

Contract development and manufacturing organizations make drugs for many companies at once, often at the same plant. One inspection outcome can therefore touch several drugs and several companies. Catalent Indiana in Bloomington, classified OAI in July 2025 and again in April 2026, is named as the maker of Geron's RYTELO on its FDA label, and in 8-Ks by Regeneron, Scholar Rock and Incyte. See the traceability chain.

Inspection records, company by company

FDA drug and biologics inspections at each company's sites, from FDA's Data Dashboard, 1 Oct 2008 to 10 Sep 2026. Sorted by number of inspections.

Every OAI at these sites

The 24 inspections classified OAI, newest first. A site keeps its FDA facility ID when it changes hands, so older entries can predate the current owner.

Reading these numbers

• Current names, full history. FDA lists each site under its current legal name, so a site's history includes inspections from before its current owner bought it.
• Matched by name. A company's sites listed under another legal name are missed (Thermo Fisher's contract sites are mostly listed as Patheon, and are counted there).
• Drugs and biologics only. Device and food inspections are not counted.
• Classifications, not 483 text. For what an OAI or a 483 means, see NAI, VAI and OAI and FDA Form 483.
• Which drugs a site makes comes from company filings and FDA drug labels; Sourcebrook links 210 US-listed companies to at least one FDA plant.