Kolmar Korea Co., Ltd.
Form 483 issued July 7, 2022 · Sejong-Si, South Korea
- Inspection
- Jul 4 – Jul 7, 2022
- Investigator
- Bryan A. Galvez
- Observations
- 1
- Pages
- 1
- FEI number
- 3010299845
In short: On July 7, 2022, FDA issued a Form 483 with 1 observation to Kolmar Korea Co., Ltd. in Sejong-Si, South Korea (FEI 3010299845) after an inspection that ran Jul 4 – Jul 7, 2022. The investigator was Bryan A. Galvez. 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(b) (1×)
What FDA observed
Preview: the opening words of each observation- 01
An adequate number of batches of each drug product are not tested to determine…
This inspection in context
Bryan A. Galvez
15 documents · 2018–2026
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in California.
The firmKolmar Korea Co., Ltd. history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.166(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Kolmar Korea Co., Ltd.?
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 Kolmar Korea Co., Ltd.?
Bryan A. Galvez is named on this Form 483, for the inspection of Jul 4 – Jul 7, 2022. Each investigator has a profile showing what they cite most.
When was Kolmar Korea Co., Ltd. inspected by FDA?
The inspection ran Jul 4 – Jul 7, 2022, and the Form 483 is dated July 7, 2022.
How do I get the full Form 483 for Kolmar Korea Co., Ltd.?
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.