Jiangsu Hengrui Pharmaceuticals Co., Ltd.
Form 483 issued January 16, 2024 · Lianyungang, China
- Inspection
- Jan 8 – Jan 16, 2024
- Investigators
- Arsen Karapetyan· Qiao Bobo
- Observations
- 8
- Pages
- 8
- FEI number
- 3007373503
In short: On January 16, 2024, FDA issued a Form 483 with 8 observations to Jiangsu Hengrui Pharmaceuticals Co., Ltd. in Lianyungang, Jiangsu (FEI 3007373503) after an inspection that ran Jan 8 – Jan 16, 2024. The investigators were Arsen Karapetyan and Qiao Bobo. Most observations concern facilities & equipment and quality system.
At a glance
Facilities & equipment and quality system account for 6 of 8 observations.
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 did not include…
- 02
Container closure systems do not provide adequate protection against foreseeable external factors in storage and use…
- 03
Equipment and utensils are not cleaned appropriately to prevent contamination that would alter the safety, identity…
- 04
The quality control unit lacks responsibility to approve all procedures or specifications impacting on the identity…
This inspection in context
Arsen Karapetyan
43 documents · 2014–2025
Cites 211.22 (responsibilities of quality control unit) more than any other section. Most of their documents are for sites in India.
The firmJiangsu Hengrui Pharmaceuticals Co., Ltd. history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.113
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Jiangsu Hengrui Pharmaceuticals Co., Ltd.?
FDA listed 8 observations on this Form 483, mostly about facilities & equipment, quality system and production. The opening words of each observation are shown on this page.
Who inspected Jiangsu Hengrui Pharmaceuticals Co., Ltd.?
Arsen Karapetyan and Qiao Bobo are named on this Form 483, for the inspection of Jan 8 – Jan 16, 2024. Each investigator has a profile showing what they cite most.
When was Jiangsu Hengrui Pharmaceuticals Co., Ltd. inspected by FDA?
The inspection ran Jan 8 – Jan 16, 2024, and the Form 483 is dated January 16, 2024.
How do I get the full Form 483 for Jiangsu Hengrui Pharmaceuticals Co., Ltd.?
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