42 of 99 registered 503B outsourcing facilities have never been inspected

The FDA's own outsourcing facility register lists 99 facilities registered under section 503B, across 28 states and territories.1 42 of them — 42.4% — carry no inspection date in the file. The other 57 do. Registering is a filing the facility makes. Inspection is something the agency does.2

An uninspected facility may have only just registered. Some did: 14 of the 42 first registered within the last twelve months. But 15 first registered more than two years ago and still have no inspection date, and the median uninspected facility has been on the register for 1.7 years.1 The longest-standing has been registered since April 2022. The register itself says the FDA "plans to inspect outsourcing facilities within a reasonable period of time following initial registration, once it is confirmed that the facility has initiated drug production and distribution" (page current as of 22 October 2026).1

The register records whether a facility intends to compound sterile preparations from bulk drug substances, the highest-risk work a 503B does and the activity behind most of the agency's compounding enforcement. 40 of the 42 facilities with no inspection date are registered for it, against 93 of the 99 facilities on the register overall.1 The uninspected group is not made up of low-risk outliers.

Texas (12) and Florida (6) account for 18 of the 42 uninspected facilities; California and New Jersey follow with 4 each.1 That tracks where 503B compounding is concentrated rather than any state-level difference in oversight: the register is federal, and so is the inspection program behind it.

Of the 57 facilities the agency has reached, all 57 were last inspected in 2025 (28) or 2026 (29).1 The register carries the most recent inspection per facility, not a full history, so this is a picture of current coverage rather than of everything the FDA has ever done. The program is active and has not yet reached 42.4% of the register.

Names link to the page for that record where one is published.

The FDA publishes the outsourcing facility register as a table on its website, with a row per registered facility and a "Last Inspection" column.1 We read the whole table as the FDA dates it, keep only the facilities it lists that day, and count the rows where that column holds no date. A facility is counted when the FDA's own file has nothing in that field.

The denominator is every facility on the register, not the subset that compounds a GLP-1. The FDA does not publish what each facility compounds, so a narrower denominator would be a guess.

An empty inspection date is a statement about the register, not about the facility. It does not mean an inspection was failed, refused, or hidden. It means the agency has not recorded one.2

1. Registration under section 503B is a filing with the FDA, not an FDA approval of the facility or its products.
2. A blank inspection date means the register records no inspection. It is not a passed inspection.
3. The register covers all 503B facilities, not only those compounding a GLP-1.