Sinsin Pharmaceutical Co., Ltd.
FDA inspection history in Sejong, South Korea, 2019 to 2025
- 1
- Warning letter
- 1
- Form 483
Every document, by year
- Warning letter
- Form 483
2019: one Form 483; 2025: one warning letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2019One Form 483, at Sejong, South Korea.
- 2025One warning letter, at Sejong, South Korea.
Cited most
Across all Sinsin Pharmaceutical Co. observations on file
- 21 CFR 211.160(b)General requirements1
- 21 CFR 211.192Production record review1
- 21 CFR 211.22(d)Responsibilities of quality control unit1
- 21 CFR 211.67(a)Equipment cleaning and maintenance1
The complete Sinsin Pharmaceutical 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
Sejong, South Korea
One warning letter and one Form 483 · 2019 to 2025 · 4 observations
Latest: Warning letter, Nov 12, 2025 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2025-11-12 | Warning letter Warning letter | Sejong, South Korea | — | $99 |
| 2019-12-13 | 483 Form 483 | Sejong, South Korea | 4 | $99 |
Investigators on these documents
FEI number 3002277609 · most recent document Nov 12, 2025
About Sinsin Pharmaceutical Co., Ltd.
How many FDA Form 483s has Sinsin Pharmaceutical Co., Ltd. received?
FDA Intel has 1 Form 483 on file for Sinsin Pharmaceutical Co., Ltd.; the most recent is dated Dec 13, 2019.
When was Sinsin Pharmaceutical Co., Ltd. last inspected by FDA?
The most recent FDA inspection document on file for Sinsin Pharmaceutical Co., Ltd. is a Form 483 dated Dec 13, 2019, for the site in Sejong, South Korea.
What did FDA cite at Sinsin Pharmaceutical Co., Ltd.?
The regulations cited most in the observations on file for Sinsin Pharmaceutical Co., Ltd. are 21 CFR 211.160(b) (General requirements), 1 time; 21 CFR 211.192 (Production record review), 1 time; 21 CFR 211.22(d) (Responsibilities of quality control unit), 1 time.
Has Sinsin Pharmaceutical Co., Ltd. received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Sinsin Pharmaceutical Co., Ltd.; the most recent is dated Nov 12, 2025.