Jiangsu Hengrui Pharmaceuticals Co., Ltd.
FDA inspection history in Lianyungang, China, 2024
- 1
- Warning letter
- 1
- Form 483
Every document, by year
- Warning letter
- Form 483
2024: one warning letter and one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2024One warning letter and one Form 483, at Lianyungang, China.
Cited most
Across all Jiangsu Hengrui Pharmaceuticals Co. observations on file
- 21 CFR 211.113Control of microbiological contamination1
- 21 CFR 211.180General requirements1
- 21 CFR 211.22Responsibilities of quality control unit1
- 21 CFR 211.52Washing and toilet facilities1
- 21 CFR 211.58Maintenance1
The complete Jiangsu Hengrui Pharmaceuticals 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
Lianyungang, China
One warning letter and one Form 483 · 2024 · 8 observations
Latest: Warning letter, Jul 11, 2024 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2024-07-11 | Warning letter Warning letter | Lianyungang, China | — | $99 |
| 2024-01-16 | 483 Form 483 | Lianyungang, China | 8 | $99 |
Investigators on these documents
FEI number 3007373503 · most recent document Jul 11, 2024
About Jiangsu Hengrui Pharmaceuticals Co., Ltd.
How many FDA Form 483s has Jiangsu Hengrui Pharmaceuticals Co., Ltd. received?
FDA Intel has 1 Form 483 on file for Jiangsu Hengrui Pharmaceuticals Co., Ltd.; the most recent is dated Jan 16, 2024.
When was Jiangsu Hengrui Pharmaceuticals Co., Ltd. last inspected by FDA?
The most recent FDA inspection document on file for Jiangsu Hengrui Pharmaceuticals Co., Ltd. is a Form 483 dated Jan 16, 2024, for the site in Lianyungang, China.
What did FDA cite at Jiangsu Hengrui Pharmaceuticals Co., Ltd.?
The regulations cited most in the observations on file for Jiangsu Hengrui Pharmaceuticals Co., Ltd. are 21 CFR 211.113 (Control of microbiological contamination), 1 time; 21 CFR 211.180 (General requirements), 1 time; 21 CFR 211.22 (Responsibilities of quality control unit), 1 time.
Has Jiangsu Hengrui Pharmaceuticals Co., Ltd. received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Jiangsu Hengrui Pharmaceuticals Co., Ltd.; the most recent is dated Jul 11, 2024.