Jiangsu Hansoh Pharmaceutical Group Co., Ltd. (FDF site)
Form 483 issued June 13, 2019 · Lianyungang, China
- Inspection
- Jun 4 – Jun 13, 2019
- Investigator
- Laurimer Kuilan-Torres
- Observations
- 4
- Pages
- 2
- FEI number
- 3008316144
In short: On June 13, 2019, FDA issued a Form 483 with 4 observations to Jiangsu Hansoh Pharmaceutical Group Co., Ltd. (FDF site) in Lianyungang, Jiangsu (FEI 3008316144) after an inspection that ran Jun 4 – Jun 13, 2019. The investigator was Laurimer Kuilan-Torres. Most observations concern production and materials; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).
At a glance
3 of 4 observations on this 483 concern production.
Most cited: 21 CFR 211.100 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
There are no written procedures for production aj the identity, strength, quality…
- 02
Written production and process…
- 03
Control procedures are not established which valli be responsible for causing…
- 04
The number of containers to be…
This inspection in context
Laurimer Kuilan-Torres
16 documents · 2015–2025
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Puerto Rico.
The firmJiangsu Hansoh Pharmaceutical Group Co., Ltd. (FDF site) history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.100
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Jiangsu Hansoh Pharmaceutical Group Co., Ltd. (FDF site)?
FDA listed 4 observations on this Form 483, mostly about production and materials. The most-cited regulation is 21 CFR 211.100 (written procedures; deviations). The opening words of each observation are shown on this page.
Who inspected Jiangsu Hansoh Pharmaceutical Group Co., Ltd. (FDF site)?
Laurimer Kuilan-Torres is named on this Form 483, for the inspection of Jun 4 – Jun 13, 2019. Each investigator has a profile showing what they cite most.
When was Jiangsu Hansoh Pharmaceutical Group Co., Ltd. (FDF site) inspected by FDA?
The inspection ran Jun 4 – Jun 13, 2019, and the Form 483 is dated June 13, 2019.
How do I get the full Form 483 for Jiangsu Hansoh Pharmaceutical Group Co., Ltd. (FDF 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.