Hillyard GMP
Form 483 issued October 8, 2021 · Saint Joseph, Missouri
- Inspection
- Oct 4 – Oct 8, 2021
- Investigators
- Carl A. Huffman· Gretchen L. Trendel
- Observations
- 1
- Pages
- 2
- FEI number
- 3009690111
In short: On October 8, 2021, FDA issued a Form 483 with 1 observation to Hillyard GMP in Saint Joseph, Missouri (FEI 3009690111) after an inspection that ran Oct 4 – Oct 8, 2021. The investigators were Carl A. Huffman and Gretchen L. Trendel. Most observations concern laboratory controls; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
1 of 1 observations on this 483 concern laboratory controls.
Most cited: 21 CFR 211.160(b) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications and test procedures…
This inspection in context
Carl A. Huffman
11 documents · 2015–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Kansas.
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 211.160(b)
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 laboratory controls. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected Hillyard GMP?
Carl A. Huffman and Gretchen L. Trendel are named on this Form 483, for the inspection of Oct 4 – Oct 8, 2021. Each investigator has a profile showing what they cite most.
When was Hillyard GMP inspected by FDA?
The inspection ran Oct 4 – Oct 8, 2021, and the Form 483 is dated October 8, 2021.
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.