Fosun Wanbang (Jiangsu) Pharmaceutical Group Co., Ltd.
Form 483 issued September 8, 2023 · Xuzhou, China
- Inspection
- Aug 28 – Sep 8, 2023
- Investigator
- Patty P. Kaewussdangkul
- Observations
- 3
- Pages
- 3
- FEI number
- 3007836611
In short: On September 8, 2023, FDA issued a Form 483 with 3 observations to Fosun Wanbang (Jiangsu) Pharmaceutical Group Co., Ltd. in Xuzhou, Jiangsu (FEI 3007836611) after an inspection that ran Aug 28 – Sep 8, 2023. The investigator was Patty P. Kaewussdangkul. Most observations concern production and quality system.
At a glance
Production and quality system account for 2 of 3 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 are not…
- 02
There is a failure to thoroughly review any unexplained discrepancy whether or not the batch…
- 03
Laboratory records are deficient in that they do not include all…
This inspection in context
Patty P. Kaewussdangkul
54 documents · 2006–2026
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in Texas.
The firmFosun Wanbang (Jiangsu) Pharmaceutical Group Co., Ltd. history
The site's inspection history, in date order.
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 Fosun Wanbang (Jiangsu) Pharmaceutical Group Co., Ltd.?
FDA listed 3 observations on this Form 483, mostly about production, quality system and laboratory controls. The opening words of each observation are shown on this page.
Who inspected Fosun Wanbang (Jiangsu) Pharmaceutical Group Co., Ltd.?
Patty P. Kaewussdangkul is named on this Form 483, for the inspection of Aug 28 – Sep 8, 2023. Each investigator has a profile showing what they cite most.
When was Fosun Wanbang (Jiangsu) Pharmaceutical Group Co., Ltd. inspected by FDA?
The inspection ran Aug 28 – Sep 8, 2023, and the Form 483 is dated September 8, 2023.
How do I get the full Form 483 for Fosun Wanbang (Jiangsu) Pharmaceutical Group Co., Ltd.?
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.