Hillyard GMP
Form 483 issued February 27, 2026 · Saint Joseph, Missouri
- Inspection
- Feb 23 – Feb 27, 2026
- Investigators
- Aerial A. Smith· Eric D. Bowles
- Observations
- 1
- Pages
- 3
- FEI number
- 3009690111
In short: On February 27, 2026, FDA issued a Form 483 with 1 observation to Hillyard GMP in Saint Joseph, Missouri (FEI 3009690111) after an inspection that ran Feb 23 – Feb 27, 2026. The investigators were Aerial A. Smith and Eric D. Bowles. Most observations concern quality system; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
1 of 1 observations on this 483 concern quality system.
Most cited: 21 CFR 211.22 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
(QUALITY SYSTEM) Written procedures for the qualification and approval of suppliers of components…
This inspection in context
Aerial A. Smith
1 document · 2026
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in Missouri.
The firmHillyard GMP history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.22
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Hillyard GMP?
FDA listed 1 observation on this Form 483, mostly about quality system. The most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit). The opening words of each observation are shown on this page.
Who inspected Hillyard GMP?
Aerial A. Smith and Eric D. Bowles are named on this Form 483, for the inspection of Feb 23 – Feb 27, 2026. Each investigator has a profile showing what they cite most.
When was Hillyard GMP inspected by FDA?
The inspection ran Feb 23 – Feb 27, 2026, and the Form 483 is dated February 27, 2026.
How do I get the full Form 483 for Hillyard GMP?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.