C&T Dream Co., Ltd.
FDA inspection history in Cheonan, 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 Cheonan, South Korea.
Cited most
Across all C&T Dream Co. observations on file
- 21 CFR 211.84(c)(2)Testing and approval or rejection of components, drug product containers, and closures2
- 21 CFR 211.110(a)Sampling and testing of in-process materials and drug products1
- 21 CFR 211.166(b)Stability testing1
- 21 CFR 211.194(a)(4)Laboratory records1
- 21 CFR 211.46(b)Ventilation, air filtration, air heating and cooling1
The complete C&T Dream 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
Cheonan, South Korea
One warning letter and one Form 483 · 2023 to 2024 · 9 observations
Latest: Warning letter, Apr 11, 2024 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-04-11 | Warning letter Warning letter | Cheonan, South Korea | — | $99 |
| 2023-11-10 | 483 Form 483 | Cheonan, South Korea | 9 | $99 |
Investigators on these documents
FEI number 3012668529 · most recent document Apr 11, 2024
About C&T Dream Co., Ltd.
How many FDA Form 483s has C&T Dream Co., Ltd. received?
FDA Intel has 1 Form 483 on file for C&T Dream Co., Ltd.; the most recent is dated Nov 10, 2023.
When was C&T Dream Co., Ltd. last inspected by FDA?
The most recent FDA inspection document on file for C&T Dream Co., Ltd. is a Form 483 dated Nov 10, 2023, for the site in Cheonan, South Korea.
What did FDA cite at C&T Dream Co., Ltd.?
The regulations cited most in the observations on file for C&T Dream Co., Ltd. are 21 CFR 211.84(c)(2) (Testing and approval or rejection of components, drug product containers, and closures), 2 times; 21 CFR 211.110(a) (Sampling and testing of in-process materials and drug products), 1 time; 21 CFR 211.166(b) (Stability testing), 1 time.
Has C&T Dream Co., Ltd. received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for C&T Dream Co., Ltd.; the most recent is dated Apr 11, 2024.