Jiangsu Hansoh Pharmaceutical Group Co., Ltd. (API site)
Form 483 issued April 22, 2015 · Lianyungang, China
- Inspection
- Apr 13 – Apr 22, 2015
- Investigator
- Elizabeth L. Edwards
- Observations
- 2
- Pages
- 1
- FEI number
- 3007086869
In short: On April 22, 2015, FDA issued a Form 483 with 2 observations to Jiangsu Hansoh Pharmaceutical Group Co., Ltd. (API site) in Lianyungang, Jiangsu (FEI 3007086869) after an inspection that ran Apr 13 – Apr 22, 2015. The investigator was Elizabeth L. Edwards. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
Facilities & equipment and production account for 2 of 2 observations.
Most cited: 21 CFR 211.67 (1×) · 211.186 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Hes firm does not maintain all manufacturing equipment in an easily…
- 02
The Master Batch Record for the production process of 4 does…
This inspection in context
Elizabeth L. Edwards
2 documents · 2012–2015
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in China.
The firmJiangsu Hansoh Pharmaceutical Group Co., Ltd. (API site) history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.67
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Jiangsu Hansoh Pharmaceutical Group Co., Ltd. (API site)?
FDA listed 2 observations on this Form 483, mostly about facilities & equipment and production. The most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance). The opening words of each observation are shown on this page.
Who inspected Jiangsu Hansoh Pharmaceutical Group Co., Ltd. (API site)?
Elizabeth L. Edwards is named on this Form 483, for the inspection of Apr 13 – Apr 22, 2015. Each investigator has a profile showing what they cite most.
When was Jiangsu Hansoh Pharmaceutical Group Co., Ltd. (API site) inspected by FDA?
The inspection ran Apr 13 – Apr 22, 2015, and the Form 483 is dated April 22, 2015.
How do I get the full Form 483 for Jiangsu Hansoh Pharmaceutical Group Co., Ltd. (API site)?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.