44 of 103 registered 503B outsourcing facilities have never been inspected

The FDA's own outsourcing facility register lists 103 facilities registered under section 503B, across 28 states and territories.1 44 of them — 42.7% — carry no inspection date in the file. The other 59 do. Registering is a filing the facility makes; inspection is something the agency does, and the register keeps the two in separate columns for exactly that reason.2

The obvious reading of an uninspected facility is that it only just registered. Some did: 15 of the 44 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 1.6 years.1 The longest-standing has been registered since April 2022. Against the FDA's stated intent to reach newly registered outsourcing facilities early, a multi-year gap is the part of this number worth quoting.

The register records whether a facility intends to compound sterile preparations from bulk drug substances — the highest-consequence thing a 503B does, and the activity behind most of the agency's compounding enforcement. 42 of the 44 facilities with no inspection date are registered for it, against 96 of the 103 facilities on the register overall.1 The uninspected group is not made up of low-risk outliers.

Texas (12), Florida (7) and California (5) account for 24 of the 44 uninspected facilities.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 59 facilities the agency has reached, 58 were inspected in 2025 (31) and 2026 (27).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. Read alongside the uninspected count, it says the program is active and has not yet come round to 42.7% of the register.

The complete list, so the count can be checked rather than taken on trust. Names link to the page for that record where one is published.

One file, one predicate. The FDA publishes the outsourcing facility register as a downloadable list with a row per registered facility and a "Date of Last Inspection" column.1 We ingest it whole and count the rows where that column is empty. There is no matching, no name resolution and no inference: a facility is counted here exactly when the agency'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 per-product registration, so a narrower denominator would have to be guessed, and a guessed denominator is worse than a wide honest one.

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

Each of these changes what the figure means. They are numbered so a quotation can name the one it breaks.

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.