Toyobo CO., Ltd.
FDA inspection history in Otsu, Japan, 2018 to 2023
- 4
- Form 483s
- 1
- Warning letter
Every document, by year
- Form 483
- Warning letter
2018: one Form 483; 2019: one Form 483; 2021: one warning letter and one Form 483; 2023: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2018–23Four Form 483s and one warning letter, at Otsu, Japan.
- 2021The longest 483 on file: 11 observations over 14 pages at Otsu, Japan.
Cited most
Across all Toyobo CO. observations on file
- 21 CFR 211.113Control of microbiological contamination4
- 21 CFR 211.68Automatic, mechanical, and electronic equipment4
- 21 CFR 211.100Written procedures; deviations3
- 21 CFR 211.194Laboratory records3
- 21 CFR 211.192Production record review2
The complete Toyobo CO. file.
All 5 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
15% off buying them one by one
Sites
Otsu, Japan
Four Form 483s · 2018 to 2023 · 24 observations
Latest: Form 483, Feb 25, 2023 →
Also: one document not tied to a site.
Documents
5 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2023-02-25 | 483 Form 483 | Otsu, Japan | 5 | $99 |
| 2021-08-19 | Warning letter Warning letter | — | — | $99 |
| 2021-02-25 | 483 Form 483 | Otsu, Japan | 11 | $99 |
| 2019-07-30 | 483 Form 483 | Otsu, Japan | 3 | $99 |
| 2018-01-23 | 483 Form 483 | Otsu, Japan | 5 | $99 |
Investigators on these documents
Arsen Karapetyan (1)Marion Michaelis (1)Michael E. Maselli (1)Michele Perry Williams (1)Roger F. Zabinski (1)Sarah E. Rhoades (1)Steven E. Bowen (1)Steven Fong (1)
FEI number 1000251214 · most recent document Feb 25, 2023
About Toyobo CO., Ltd.
How many FDA Form 483s has Toyobo CO., Ltd. received?
FDA Intel has 4 Form 483s on file for Toyobo CO., Ltd.; the most recent is dated Feb 25, 2023.
When was Toyobo CO., Ltd. last inspected by FDA?
The most recent FDA inspection document on file for Toyobo CO., Ltd. is a Form 483 dated Feb 25, 2023, for the site in Otsu, Japan.
What did FDA cite at Toyobo CO., Ltd.?
The regulations cited most in the observations on file for Toyobo CO., Ltd. are 21 CFR 211.113 (Control of microbiological contamination), 4 times; 21 CFR 211.68 (Automatic, mechanical, and electronic equipment), 4 times; 21 CFR 211.100 (Written procedures; deviations), 3 times.
Has Toyobo CO., Ltd. received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Toyobo CO., Ltd.; the most recent is dated Aug 19, 2021.