Zhejiang Tianyu Pharmaceutical Co., Ltd.
FDA inspection history across 2 sites, 2015 to 2024
- 4
- Form 483s
- 1
- Warning letter
- 1
- Close-out
Every document, by year
- Form 483
- Warning letter
- Close-out
2015: one Form 483; 2019: one Form 483; 2022: one warning letter and one Form 483; 2024: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2015One Form 483, at Taizhou, China.
- 2019One Form 483, at Taizhou, China.
- 2019The longest 483 on file: 5 observations over 3 pages at Taizhou, China.
- 2022–24Two Form 483s and one warning letter, at Taizhou City, China and Taizhou, China.
Cited most
Across all Zhejiang Tianyu Pharmaceutical Co. observations on file
- 21 CFR 211.67Equipment cleaning and maintenance3
- 21 CFR 211.192Production record review2
- 21 CFR 211.122Materials examination and usage criteria1
- 21 CFR 211.142Warehousing procedures1
- 21 CFR 211.160General requirements1
The complete Zhejiang Tianyu Pharmaceutical Co. file.
All 6 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
15% off buying them one by one
Sites
Taizhou, China
Three Form 483s · 2015 to 2024 · 10 observations
Latest: Form 483, Nov 29, 2024 →Taizhou City, China
One Form 483 · 2022 · 3 observations
Latest: Form 483, Mar 4, 2022 →
Also: two documents not tied to a site.
Documents
6 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-11-29 | 483 Form 483 | Taizhou, China | 2 | $99 |
| 2022-08-17 | Warning letter Warning letter | — | — | $99 |
| 2022-03-04 | 483 Form 483 | Taizhou City, China | 3 | $99 |
| 2019-04-12 | 483 Form 483 | Taizhou, China | 5 | $99 |
| 2015-06-12 | 483 Form 483 | Taizhou, China | 3 | $99 |
| Undated | Close-out Close-out letter | — | — | $99 |
Investigators on these documents
Alan A. Rivera (1)Dennis Cantellops (1)Jose E. Melendez (1)Laimimer Kuilan-Torres (1)Laurimer Kuilan-Torres (1)Marcus A. Ray (1)Pratik S. Upadhyay (1)
FEI number 3010972581 · most recent document Nov 29, 2024
About Zhejiang Tianyu Pharmaceutical Co., Ltd.
How many FDA Form 483s has Zhejiang Tianyu Pharmaceutical Co., Ltd. received?
FDA Intel has 4 Form 483s on file for Zhejiang Tianyu Pharmaceutical Co., Ltd.; the most recent is dated Nov 29, 2024.
When was Zhejiang Tianyu Pharmaceutical Co., Ltd. last inspected by FDA?
The most recent FDA inspection document on file for Zhejiang Tianyu Pharmaceutical Co., Ltd. is a Form 483 dated Nov 29, 2024, for the site in Taizhou, China.
What did FDA cite at Zhejiang Tianyu Pharmaceutical Co., Ltd.?
The regulations cited most in the observations on file for Zhejiang Tianyu Pharmaceutical Co., Ltd. are 21 CFR 211.67 (Equipment cleaning and maintenance), 3 times; 21 CFR 211.192 (Production record review), 2 times; 21 CFR 211.122 (Materials examination and usage criteria), 1 time.
Has Zhejiang Tianyu Pharmaceutical Co., Ltd. received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Zhejiang Tianyu Pharmaceutical Co., Ltd.; the most recent is dated Aug 17, 2022.