Buckeye International, Inc.
Form 483 issued March 1, 2017 · Maryland Heights, Missouri
- Inspection
- Mar 1, 2017
- Investigator
- Michele Perry Williams
- Observations
- 10
- Pages
- 6
- FEI number
- 3001419679
In short: On March 1, 2017, FDA issued a Form 483 with 10 observations to Buckeye International, Inc. in Maryland Heights, Missouri (FEI 3001419679) after an inspection that ran Mar 1, 2017. The investigator was Michele Perry Williams. Most observations concern quality system and facilities & equipment.
At a glance
Quality system and facilities & equipment account for 6 of 10 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Backup data is not assured as secure from alteration, erasure or loss through keeping hard…
- 02
The quality control unit lacks authority to fully investigate…
- 03
Incoming drug product containers and closures are not stored under quarantine until they have been tested…
- 04
Written procedures describing the handling of complaints do not include provisions for review by the quality…
This inspection in context
Michele Perry Williams
22 documents · 2009–2023
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Missouri.
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 211.68
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Buckeye International, Inc.?
FDA listed 10 observations on this Form 483, mostly about quality system, facilities & equipment and materials. The opening words of each observation are shown on this page.
Who inspected Buckeye International, Inc.?
Michele Perry Williams is named on this Form 483, for the inspection of Mar 1, 2017. Each investigator has a profile showing what they cite most.
When was Buckeye International, Inc. inspected by FDA?
The inspection ran Mar 1, 2017, and the Form 483 is dated March 1, 2017.
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.