Natuzen Co., Ltd.
FDA inspection history in Incheon, South Korea, 2024
- 1
- Form 483
- 1
- Warning letter
- 1
- Close-out
Every document, by year
- Form 483
- Warning letter
- Close-out
2024: one Form 483 and one warning letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2024One Form 483 and one warning letter, at Incheon, South Korea.
Cited most
Across all Natuzen Co. observations on file
- 21 CFR 211.100(a)Written procedures; deviations1
- 21 CFR 211.160(b)General requirements1
- 21 CFR 211.22(d)Responsibilities of quality control unit1
- 21 CFR 211.25(a)Personnel qualifications1
The complete Natuzen Co. file.
All 3 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
Incheon, South Korea
One Form 483 · 2024 · 4 observations
Latest: Form 483, Nov 21, 2024 →
Also: two documents not tied to a site.
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-11-21 | 483 Form 483 | Incheon, South Korea | 4 | $99 |
| 2024-05-03 | Warning letter Warning letter | — | — | $99 |
| Undated | Close-out Close-out letter | — | — | $99 |
Investigators on these documents
FEI number 3006731547 · most recent document Nov 21, 2024
About Natuzen Co., Ltd.
How many FDA Form 483s has Natuzen Co., Ltd. received?
FDA Intel has 1 Form 483 on file for Natuzen Co., Ltd.; the most recent is dated Nov 21, 2024.
When was Natuzen Co., Ltd. last inspected by FDA?
The most recent FDA inspection document on file for Natuzen Co., Ltd. is a Form 483 dated Nov 21, 2024, for the site in Incheon, South Korea.
What did FDA cite at Natuzen Co., Ltd.?
The regulations cited most in the observations on file for Natuzen Co., Ltd. are 21 CFR 211.100(a) (Written procedures; deviations), 1 time; 21 CFR 211.160(b) (General requirements), 1 time; 21 CFR 211.22(d) (Responsibilities of quality control unit), 1 time.
Has Natuzen Co., Ltd. received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Natuzen Co., Ltd.; the most recent is dated May 3, 2024.