Centaur, Inc.
Form 483 issued February 1, 2024 · Olathe, Kansas
- Inspection
- Jan 29 – Feb 1, 2024
- Investigator
- Conner N. Mann
- Observations
- 2
- Pages
- 4
- FEI number
- 1931750
In short: On February 1, 2024, FDA issued a Form 483 with 2 observations to Centaur, Inc. in Olathe, Kansas (FEI 1931750) after an inspection that ran Jan 29 – Feb 1, 2024. The investigator was Conner N. Mann. Most observations concern quality system and materials; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
Quality system and materials account for 2 of 2 observations.
Most cited: 21 CFR 211.192 (1×) · 211.80(a) (1×)
What FDA observed
Preview: the opening words of each observation- 01
There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch…
- 02
Written procedures are lacking which describe in sufficient detail…
This inspection in context
Conner N. Mann
7 documents · 2023–2025
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in Kansas.
The firmCentaur, Inc. history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Centaur, Inc.?
FDA listed 2 observations on this Form 483, mostly about quality system and materials. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Centaur, Inc.?
Conner N. Mann is named on this Form 483, for the inspection of Jan 29 – Feb 1, 2024. Each investigator has a profile showing what they cite most.
When was Centaur, Inc. inspected by FDA?
The inspection ran Jan 29 – Feb 1, 2024, and the Form 483 is dated February 1, 2024.
How do I get the full Form 483 for Centaur, 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.