Jiangsu Hansoh Pharmaceutical Group Co., Ltd. (FDF site)
Form 483 issued December 16, 2016 · Lianyungang, China
- Inspection
- Dec 5 – Dec 16, 2016
- Investigator
- Noreen Muniz
- Observations
- 7
- Pages
- 8
- FEI number
- 3008316144
In short: On December 16, 2016, FDA issued a Form 483 with 7 observations to Jiangsu Hansoh Pharmaceutical Group Co., Ltd. (FDF site) in Lianyungang, Jiangsu (FEI 3008316144) after an inspection that ran Dec 5 – Dec 16, 2016. The investigator was Noreen Muniz. Most observations concern facilities & equipment and production; the most-cited regulation is 21 CFR 211.42 (design and construction features).
At a glance
Facilities & equipment and production account for 5 of 7 observations.
Most cited: 21 CFR 211.42 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are…
- 02
Aseptic processing areas are deficient regarding the system…
- 03
Aseptic processing areas are deficient regarding the system for cleaning and disinfecting the room and equipment…
- 04
Written procedures for the cleaning and maintenance of equipment are…
This inspection in context
Noreen Muniz
24 documents · 2008–2022
Cites 211.160 (general requirements) 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 211.42
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 7 observations on this Form 483, mostly about facilities & equipment, production and laboratory controls. The most-cited regulation is 21 CFR 211.42 (design and construction features). The opening words of each observation are shown on this page.
Who inspected Jiangsu Hansoh Pharmaceutical Group Co., Ltd. (FDF site)?
Noreen Muniz is named on this Form 483, for the inspection of Dec 5 – Dec 16, 2016. 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 Dec 5 – Dec 16, 2016, and the Form 483 is dated December 16, 2016.
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.