Suzhou Suncadia Biopharmaceuticals Co. Ltd.
Form 483 issued January 6, 2025 · Suzhou, China
- Inspection
- Dec 30, 2024 – Jan 6, 2025
- Investigators
- Jiangsong Jiang· Viwel Li
- Observations
- 3
- Pages
- 3
- FEI number
- 3015786877
In short: On January 6, 2025, FDA issued a Form 483 with 3 observations to Suzhou Suncadia Biopharmaceuticals Co. Ltd. in Suzhou, China (FEI 3015786877) after an inspection that ran Dec 30, 2024 – Jan 6, 2025. The investigators were Jiangsong Jiang and Viwel Li. Most observations concern production and facilities & equipment.
At a glance
2 of 3 observations on this 483 concern production.
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
Appropriate visual inspection (VI) procedures designed to assure drug product quality…
- 03
Automatic or electronic equipment, including ccmputers or related systems, are not routinely calibrated, inspected, or checked…
This inspection in context
Jiangsong Jiang
3 documents · 2025
Cites 211.113 (control of microbiological contamination) more than any other section. Most of their documents are for sites in China.
The firmSuzhou Suncadia Biopharmaceuticals Co. Ltd. history
All 3 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 Suzhou Suncadia Biopharmaceuticals Co. Ltd.?
FDA listed 3 observations on this Form 483, mostly about production and facilities & equipment. The opening words of each observation are shown on this page.
Who inspected Suzhou Suncadia Biopharmaceuticals Co. Ltd.?
Jiangsong Jiang and Viwel Li are named on this Form 483, for the inspection of Dec 30, 2024 – Jan 6, 2025. Each investigator has a profile showing what they cite most.
When was Suzhou Suncadia Biopharmaceuticals Co. Ltd. inspected by FDA?
The inspection ran Dec 30, 2024 – Jan 6, 2025, and the Form 483 is dated January 6, 2025.
How do I get the full Form 483 for Suzhou Suncadia Biopharmaceuticals 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.