Buckeye International, Inc.
Form 483 issued June 4, 2021 · Maryland Heights, Missouri
- Inspection
- Jun 1 – Jun 4, 2021
- Investigator
- Norman K. Starks
- Observations
- 1
- Pages
- 2
- FEI number
- 3001419679
In short: On June 4, 2021, FDA issued a Form 483 with 1 observation to Buckeye International, Inc. in Maryland Heights, Missouri (FEI 3001419679) after an inspection that ran Jun 1 – Jun 4, 2021. The investigator was Norman K. Starks. Most observations concern laboratory controls; the most-cited regulation is 21 CFR 211.166 (stability testing).
At a glance
1 of 1 observations on this 483 concern laboratory controls.
Most cited: 21 CFR 211.166 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The written stability program testing program…
This inspection in context
Norman K. Starks
10 documents · 2018–2024
Cites 211.166 (stability testing) more than any other section. Most of their documents are for sites in Illinois.
The firmBuckeye International, Inc. history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.166
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Buckeye International, Inc.?
FDA listed 1 observation on this Form 483, mostly about laboratory controls. The most-cited regulation is 21 CFR 211.166 (stability testing). The opening words of each observation are shown on this page.
Who inspected Buckeye International, Inc.?
Norman K. Starks is named on this Form 483, for the inspection of Jun 1 – Jun 4, 2021. Each investigator has a profile showing what they cite most.
When was Buckeye International, Inc. inspected by FDA?
The inspection ran Jun 1 – Jun 4, 2021, and the Form 483 is dated June 4, 2021.
How do I get the full Form 483 for Buckeye International, Inc.?
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.