Jiangsu Hansoh Pharmaceutical Group Co., Ltd. (FDF site)
FDA inspection history in Lianyungang, China, 2016 to 2019
- 2
- Form 483s
Every document, by year
- Form 483
2016: one Form 483; 2019: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2016One Form 483, at Lianyungang, China.
- 2016The longest 483 on file: 7 observations over 8 pages at Lianyungang, China.
- 2019One Form 483, at Lianyungang, China.
Cited most
Across all Jiangsu Hansoh Pharmaceutical Group Co., Ltd. (FDF site) observations on file
- 21 CFR 211.100Written procedures; deviations3
- 21 CFR 211.42Design and construction features2
- 21 CFR 211.110Sampling and testing of in-process materials and drug products1
- 21 CFR 211.113Control of microbiological contamination1
- 21 CFR 211.160General requirements1
The complete Jiangsu Hansoh Pharmaceutical Group Co., Ltd. (FDF site) 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
Two Form 483s · 2016 to 2019 · 7 observations
Latest: Form 483, Jun 13, 2019 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2019-06-13 | 483 Form 483 | Lianyungang, China | — | $99 |
| 2016-12-16 | 483 Form 483 | Lianyungang, China | 7 | $99 |
Investigators on these documents
FEI number 3008316144 · most recent document Jun 13, 2019
About Jiangsu Hansoh Pharmaceutical Group Co., Ltd. (FDF site)
How many FDA Form 483s has Jiangsu Hansoh Pharmaceutical Group Co., Ltd. (FDF site) received?
FDA Intel has 2 Form 483s on file for Jiangsu Hansoh Pharmaceutical Group Co., Ltd. (FDF site); the most recent is dated Jun 13, 2019.
When was Jiangsu Hansoh Pharmaceutical Group Co., Ltd. (FDF site) last inspected by FDA?
The most recent FDA inspection document on file for Jiangsu Hansoh Pharmaceutical Group Co., Ltd. (FDF site) is a Form 483 dated Jun 13, 2019, for the site in Lianyungang, China.
What did FDA cite at Jiangsu Hansoh Pharmaceutical Group Co., Ltd. (FDF site)?
The regulations cited most in the observations on file for Jiangsu Hansoh Pharmaceutical Group Co., Ltd. (FDF site) are 21 CFR 211.100 (Written procedures; deviations), 3 times; 21 CFR 211.42 (Design and construction features), 2 times; 21 CFR 211.110 (Sampling and testing of in-process materials and drug products), 1 time.