First Cham Co., Ltd.
FDA inspection history in Eumseong, South Korea, 2023 to 2024
- 1
- Warning letter
- 1
- Form 483
Every document, by year
- Warning letter
- Form 483
2023: one Form 483; 2024: one warning letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2023–24One Form 483 and one warning letter, at Eumseong, South Korea.
Cited most
Across all First Cham Co. observations on file
- 21 CFR 211.165(f)Testing and release for distribution1
- 21 CFR 211.166(a)Stability testing1
- 21 CFR 211.194(a)(2)Laboratory records1
- 21 CFR 211.22(d)Responsibilities of quality control unit1
- 21 CFR 211.25(a)Personnel qualifications1
The complete First Cham Co. file.
All 2 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Eumseong, South Korea
One warning letter and one Form 483 · 2023 to 2024 · 8 observations
Latest: Warning letter, Apr 3, 2024 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-04-03 | Warning letter Warning letter | Eumseong, South Korea | — | $99 |
| 2023-10-27 | 483 Form 483 | Eumseong, South Korea | 8 | $99 |
Investigators on these documents
FEI number 3010970108 · most recent document Apr 3, 2024
About First Cham Co., Ltd.
How many FDA Form 483s has First Cham Co., Ltd. received?
FDA Intel has 1 Form 483 on file for First Cham Co., Ltd.; the most recent is dated Oct 27, 2023.
When was First Cham Co., Ltd. last inspected by FDA?
The most recent FDA inspection document on file for First Cham Co., Ltd. is a Form 483 dated Oct 27, 2023, for the site in Eumseong, South Korea.
What did FDA cite at First Cham Co., Ltd.?
The regulations cited most in the observations on file for First Cham Co., Ltd. are 21 CFR 211.165(f) (Testing and release for distribution), 1 time; 21 CFR 211.166(a) (Stability testing), 1 time; 21 CFR 211.194(a)(2) (Laboratory records), 1 time.
Has First Cham Co., Ltd. received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for First Cham Co., Ltd.; the most recent is dated Apr 3, 2024.