Sam Chun Dang Pharm Co, Ltd
FDA inspection history in Hwaseong, South Korea, 2019 to 2020
- 1
- Close-out
- 1
- Form 483
Every document, by year
- Close-out
- Form 483
2019: one Form 483; 2020: one close-out letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2019–20One Form 483 and one close-out letter, at Hwaseong, South Korea.
Cited most
Across all Sam Chun Dang Pharm Co observations on file
- 21 CFR 211.160(b)General requirements3
- 21 CFR 211.42(c)(10)Design and construction features3
- 21 CFR 211.68(b)Automatic, mechanical, and electronic equipment2
- 21 CFR 211.165(b)Testing and release for distribution1
- 21 CFR 211.188(b)Batch production and control records1
The complete Sam Chun Dang Pharm 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
Hwaseong, South Korea
One close-out letter and one Form 483 · 2019 to 2020 · 14 observations
Latest: Close-out, May 13, 2020 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2020-05-13 | Close-out Close-out letter | Hwaseong, South Korea | — | $99 |
| 2019-10-25 | 483 Form 483 | Hwaseong, South Korea | 14 | $99 |
Investigators on these documents
FEI number 3008425092 · most recent document May 13, 2020
About Sam Chun Dang Pharm Co, Ltd
How many FDA Form 483s has Sam Chun Dang Pharm Co, Ltd received?
FDA Intel has 1 Form 483 on file for Sam Chun Dang Pharm Co, Ltd; the most recent is dated Oct 25, 2019.
When was Sam Chun Dang Pharm Co, Ltd last inspected by FDA?
The most recent FDA inspection document on file for Sam Chun Dang Pharm Co, Ltd is a Form 483 dated Oct 25, 2019, for the site in Hwaseong, South Korea.
What did FDA cite at Sam Chun Dang Pharm Co, Ltd?
The regulations cited most in the observations on file for Sam Chun Dang Pharm Co, Ltd are 21 CFR 211.160(b) (General requirements), 3 times; 21 CFR 211.42(c)(10) (Design and construction features), 3 times; 21 CFR 211.68(b) (Automatic, mechanical, and electronic equipment), 2 times.