Linhai Tianyu Pharmaceutical Co., Ltd.
FDA inspection history in Taizhou, China, 2019 to 2023
- 2
- Form 483s
Every document, by year
- Form 483
2019: one Form 483; 2023: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2019One Form 483, at Taizhou, China.
- 2019The longest 483 on file: 10 observations over 6 pages at Taizhou, China.
- 2023One Form 483, at Taizhou, China.
Cited most
Across all Linhai Tianyu Pharmaceutical Co. observations on file
- 21 CFR 211.67Equipment cleaning and maintenance4
- 21 CFR 211.160General requirements2
- 21 CFR 211.22Responsibilities of quality control unit2
- 21 CFR 211.58Maintenance2
- 21 CFR 211.68Automatic, mechanical, and electronic equipment2
The complete Linhai Tianyu 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
Taizhou, China
Two Form 483s · 2019 to 2023 · 17 observations
Latest: Form 483, Sep 15, 2023 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2023-09-15 | 483 Form 483 | Taizhou, China | 7 | $99 |
| 2019-04-19 | 483 Form 483 | Taizhou, China | 10 | $99 |
Investigators on these documents
Arsen Karapetyan (1)Joe D. Hustedt (1)Joel D. Hustedt (1)Sebreverse Cl Arsen Karapetyan (1)
FEI number 3013345425 · most recent document Sep 15, 2023
About Linhai Tianyu Pharmaceutical Co., Ltd.
How many FDA Form 483s has Linhai Tianyu Pharmaceutical Co., Ltd. received?
FDA Intel has 2 Form 483s on file for Linhai Tianyu Pharmaceutical Co., Ltd.; the most recent is dated Sep 15, 2023.
When was Linhai Tianyu Pharmaceutical Co., Ltd. last inspected by FDA?
The most recent FDA inspection document on file for Linhai Tianyu Pharmaceutical Co., Ltd. is a Form 483 dated Sep 15, 2023, for the site in Taizhou, China.
What did FDA cite at Linhai Tianyu Pharmaceutical Co., Ltd.?
The regulations cited most in the observations on file for Linhai Tianyu Pharmaceutical Co., Ltd. are 21 CFR 211.67 (Equipment cleaning and maintenance), 4 times; 21 CFR 211.160 (General requirements), 2 times; 21 CFR 211.22 (Responsibilities of quality control unit), 2 times.