First Cham Co., Ltd.
Form 483 issued October 27, 2023 · Eumseong, South Korea
- Inspection
- Oct 23 – Oct 27, 2023
- Investigator
- Wayne D. McGrath
- Observations
- 8
- Pages
- 5
- FEI number
- 3010970108
In short: On October 27, 2023, FDA issued a Form 483 with 8 observations to First Cham Co., Ltd. in Eumseong, Chungcheongbuk (FEI 3010970108) after an inspection that ran Oct 23 – Oct 27, 2023. The investigator was Wayne D. McGrath. Most observations concern laboratory controls and quality system.
At a glance
Laboratory controls and quality system account for 5 of 8 observations.
What FDA observed
Preview: the opening words of each observation- 01
Dmg products failing to meet established specifications and quality control…
- 02
The responsibilities and procedures applicable to the quality control unit are not in…
- 03
(the Republic of) Appropriate controls are not exercised over computers or related systems to assure that…
- 04
GMP training is not conducted on a continuing basis and with sufficient frequency to assure that…
This inspection in context
Wayne D. McGrath
33 documents · 2018–2025
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
The firmFirst Cham 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 211.165(f)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at First Cham Co., Ltd.?
FDA listed 8 observations on this Form 483, mostly about laboratory controls, quality system and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected First Cham Co., Ltd.?
Wayne D. McGrath is named on this Form 483, for the inspection of Oct 23 – Oct 27, 2023. Each investigator has a profile showing what they cite most.
When was First Cham Co., Ltd. inspected by FDA?
The inspection ran Oct 23 – Oct 27, 2023, and the Form 483 is dated October 27, 2023.
How do I get the full Form 483 for First Cham 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.