Tianjin Asymchem Pharmaceuticals Co., Ltd.
FDA inspection history in Tianjin, China, 2019 to 2024
- 3
- Form 483s
Every document, by year
- Form 483
2019: one Form 483; 2021: one Form 483; 2024: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2019–21Two Form 483s, at Tianjin, China.
- 2019The longest 483 on file: 5 observations over 6 pages at Tianjin, China.
- 2024One Form 483, at Tianjin, China.
Cited most
Across all Tianjin Asymchem Pharmaceuticals Co. observations on file
- 21 CFR 211.100Written procedures; deviations1
- 21 CFR 211.160General requirements1
- 21 CFR 211.166Stability testing1
- 21 CFR 211.186Master production and control records1
- 21 CFR 211.22Responsibilities of quality control unit1
The complete Tianjin Asymchem Pharmaceuticals 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
Tianjin, China
Three Form 483s · 2019 to 2024 · 8 observations
Latest: Form 483, Mar 29, 2024 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-03-29 | 483 Form 483 | Tianjin, China | 2 | $99 |
| 2021-10-19 | 483 Form 483 | Tianjin, China | 1 | $99 |
| 2019-12-06 | 483 Form 483 | Tianjin, China | 5 | $99 |
Investigators on these documents
Laurin Kailan-Tones (1)Marijo B. Kambere (1)Wenzheng Zhang (1)
FEI number 3013090624 · most recent document Mar 29, 2024
About Tianjin Asymchem Pharmaceuticals Co., Ltd.
How many FDA Form 483s has Tianjin Asymchem Pharmaceuticals Co., Ltd. received?
FDA Intel has 3 Form 483s on file for Tianjin Asymchem Pharmaceuticals Co., Ltd.; the most recent is dated Mar 29, 2024.
When was Tianjin Asymchem Pharmaceuticals Co., Ltd. last inspected by FDA?
The most recent FDA inspection document on file for Tianjin Asymchem Pharmaceuticals Co., Ltd. is a Form 483 dated Mar 29, 2024, for the site in Tianjin, China.
What did FDA cite at Tianjin Asymchem Pharmaceuticals Co., Ltd.?
The regulations cited most in the observations on file for Tianjin Asymchem Pharmaceuticals Co., Ltd. are 21 CFR 211.100 (Written procedures; deviations), 1 time; 21 CFR 211.160 (General requirements), 1 time; 21 CFR 211.166 (Stability testing), 1 time.