Neogen Corporation
Form 483 issued March 16, 2021 · Lexington, Kentucky
- Inspection
- Mar 8 – Mar 16, 2021
- Investigators
- Jon P. Antoniou· Logan T. Williams
- Observations
- 5
- Pages
- 5
- FEI number
- 3009631819
In short: On March 16, 2021, FDA issued a Form 483 with 5 observations to Neogen Corporation in Lexington, Kentucky (FEI 3009631819) after an inspection that ran Mar 8 – Mar 16, 2021. The investigators were Jon P. Antoniou and Logan T. Williams. Most observations concern laboratory controls and packaging & labeling; the most-cited regulation is 21 CFR 211.122 (materials examination and usage criteria).
At a glance
Laboratory controls and packaging & labeling account for 4 of 5 observations.
What FDA observed
Preview: the opening words of each observation- 01
Laboratory records are deficient in that they do not include a complete record of all…
- 02
Drug products are not stored under appropriate conditions of temperature so that their identity, strength, quality…
- 03
The written stability testing…
- 04
Access to the storage area for labels and labeling materials is not…
This inspection in context
Jon P. Antoniou
4 documents · 2019–2021
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Indiana.
The firmNeogen Corporation history
All 4 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.194(a)(4)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Neogen Corporation?
FDA listed 5 observations on this Form 483, mostly about laboratory controls, packaging & labeling and materials. The most-cited regulation is 21 CFR 211.122 (materials examination and usage criteria). The opening words of each observation are shown on this page.
Who inspected Neogen Corporation?
Jon P. Antoniou and Logan T. Williams are named on this Form 483, for the inspection of Mar 8 – Mar 16, 2021. Each investigator has a profile showing what they cite most.
When was Neogen Corporation inspected by FDA?
The inspection ran Mar 8 – Mar 16, 2021, and the Form 483 is dated March 16, 2021.
How do I get the full Form 483 for Neogen Corporation?
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.