Buckeye International, Inc.
Form 483 issued June 28, 2019 · Maryland Heights, Missouri
- Inspection
- Jun 25 – Jun 28, 2019
- Investigator
- Norman K. Starks
- Observations
- 6
- Pages
- 6
- FEI number
- 3001419679
In short: On June 28, 2019, FDA issued a Form 483 with 6 observations to Buckeye International, Inc. in Maryland Heights, Missouri (FEI 3001419679) after an inspection that ran Jun 25 – Jun 28, 2019. The investigator was Norman K. Starks. Most observations concern laboratory controls and quality system; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Laboratory controls and quality system account for 4 of 6 observations.
Most cited: 21 CFR 211.160 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Laboratory Controls do not include the establishment of scientifically sound and appropriate specifications, standards, sampling plans…
- 02
There are no written procedures for production and process controls design to assure that the drug…
- 03
Written procedures are not reviewed and approved…
- 04
Written procedures describing the handling of complaints do not include provisions for review by the quality…
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 211.160
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Buckeye International, Inc.?
FDA listed 6 observations on this Form 483, mostly about laboratory controls, quality system and materials. The most-cited regulation is 21 CFR 211.160 (general requirements). 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 25 – Jun 28, 2019. Each investigator has a profile showing what they cite most.
When was Buckeye International, Inc. inspected by FDA?
The inspection ran Jun 25 – Jun 28, 2019, and the Form 483 is dated June 28, 2019.
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.