Yuki Gosei Kogyo Co., Ltd. Ochiai 788, Joban Nishigo-machi
FDA inspection history across 2 sites, 2010 to 2021
- 2
- Form 483s
- 1
- Close-out
- 1
- Warning letter
Every document, by year
- Form 483
- Close-out
- Warning letter
2010: one warning letter; 2017: one Form 483; 2018: one close-out letter; 2021: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2010One warning letter.
- 2017–18One Form 483 and one close-out letter, at Iwaki-shi, Japan.
- 2021One Form 483, at JOBANNISHIGOMACHI, Japan.
- 2021The longest 483 on file: 4 observations over 3 pages at JOBANNISHIGOMACHI, Japan.
Cited most
Across all Yuki Gosei Kogyo Co., Ltd. Ochiai 788, Joban Nishigo-machi observations on file
- 21 CFR 211.160General requirements3
- 21 CFR 211.192Production record review2
- 21 CFR 211.194Laboratory records1
- 21 CFR 211.22Responsibilities of quality control unit1
The complete Yuki Gosei Kogyo Co., Ltd. Ochiai 788, Joban Nishigo-machi file.
All 4 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
JOBANNISHIGOMACHI, Japan
One Form 483 · 2021 · 4 observations
Latest: Form 483, Jul 28, 2021 →Iwaki-shi, Japan
One Form 483 · 2017 · 1 observation
Latest: Form 483, Nov 17, 2017 →
Also: two documents not tied to a site.
Documents
4 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2021-07-28 | 483 Form 483 | JOBANNISHIGOMACHI, Japan | 4 | $99 |
| 2018-07-17 | Close-out Close-out letter | — | — | $99 |
| 2017-11-17 | 483 Form 483 | Iwaki-shi, Japan | 1 | $99 |
| 2010-12-09 | Warning letter Warning letter | — | — | $99 |
Investigators on these documents
FEI number 3002808534 · most recent document Jul 28, 2021
About Yuki Gosei Kogyo Co., Ltd. Ochiai 788, Joban Nishigo-machi
How many FDA Form 483s has Yuki Gosei Kogyo Co., Ltd. Ochiai 788, Joban Nishigo-machi received?
FDA Intel has 2 Form 483s on file for Yuki Gosei Kogyo Co., Ltd. Ochiai 788, Joban Nishigo-machi; the most recent is dated Jul 28, 2021.
When was Yuki Gosei Kogyo Co., Ltd. Ochiai 788, Joban Nishigo-machi last inspected by FDA?
The most recent FDA inspection document on file for Yuki Gosei Kogyo Co., Ltd. Ochiai 788, Joban Nishigo-machi is a Form 483 dated Jul 28, 2021, for the site in JOBANNISHIGOMACHI, Japan.
What did FDA cite at Yuki Gosei Kogyo Co., Ltd. Ochiai 788, Joban Nishigo-machi?
The regulations cited most in the observations on file for Yuki Gosei Kogyo Co., Ltd. Ochiai 788, Joban Nishigo-machi are 21 CFR 211.160 (General requirements), 3 times; 21 CFR 211.192 (Production record review), 2 times; 21 CFR 211.194 (Laboratory records), 1 time.
Has Yuki Gosei Kogyo Co., Ltd. Ochiai 788, Joban Nishigo-machi received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Yuki Gosei Kogyo Co., Ltd. Ochiai 788, Joban Nishigo-machi; the most recent is dated Dec 9, 2010.