Kolmar Korea Co., Ltd.
Form 483 issued February 16, 2024 · Sejong-Si, South Korea
- Inspection
- Feb 8 – Feb 16, 2024
- Investigator
- Saleem A. Akhtar
- Observations
- 6
- Pages
- 7
- FEI number
- 3010299845
In short: On February 16, 2024, FDA issued a Form 483 with 6 observations to Kolmar Korea Co., Ltd. in Sejong-Si, South Korea (FEI 3010299845) after an inspection that ran Feb 8 – Feb 16, 2024. The investigator was Saleem A. Akhtar. Most observations concern laboratory controls and production; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Observations span 4 systems, led by laboratory controls.
What FDA observed
Preview: the opening words of each observation- 01
Determinations of conformance to appropriate written specifications for acceptance are…
- 02
The batch production and control records are deficient in that they do not include documentation of…
- 03
Appropriate controls are not exercised over computers or related systems to assure that changes in master…
- 04
Laboratory controls do not include the establishment of scientifically sound and appropriate specifications designed to assure…
This inspection in context
Saleem A. Akhtar
35 documents · 2004–2026
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in India.
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 211.160(b)(3)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Kolmar Korea Co., Ltd.?
FDA listed 6 observations on this Form 483, mostly about laboratory controls, production and facilities & equipment. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected Kolmar Korea Co., Ltd.?
Saleem A. Akhtar is named on this Form 483, for the inspection of Feb 8 – Feb 16, 2024. Each investigator has a profile showing what they cite most.
When was Kolmar Korea Co., Ltd. inspected by FDA?
The inspection ran Feb 8 – Feb 16, 2024, and the Form 483 is dated February 16, 2024.
How do I get the full Form 483 for Kolmar Korea Co., Ltd.?
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