Suzhou Suncadia Biopharmaceuticals Co. Ltd.
FDA inspection history in Suzhou, China, 2023 to 2025
- 3
- Form 483s
Every document, by year
- Form 483
2023: two Form 483s; 2025: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2023–25Three Form 483s, at Suzhou, China.
- 2023The longest 483 on file: 10 observations over 10 pages at Suzhou, China.
Cited most
Across all Suzhou Suncadia Biopharmaceuticals Co. observations on file
- 21 CFR 211.113Control of microbiological contamination6
- 21 CFR 211.100Written procedures; deviations3
- 21 CFR 211.160General requirements3
- 21 CFR 211.68Automatic, mechanical, and electronic equipment3
- 21 CFR 211.165Testing and release for distribution2
The complete Suzhou Suncadia Biopharmaceuticals Co. file.
All 3 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Suzhou, China
Three Form 483s · 2023 to 2025 · 23 observations
Latest: Form 483, Jan 6, 2025 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2025-01-06 | 483 Form 483 | Suzhou, China | 3 | $99 |
| 2023-12-15 | 483 Form 483 | Suzhou, China | 10 | $99 |
| 2023-12-14 | 483 Form 483 | Suzhou, China | 10 | $99 |
Investigators on these documents
Yiwei Li (2)Jiangsong Jiang (1)Richard Ledwidge (1)Viwel Li (1)Zhang Zhao (1)
FEI number 3015786877 · most recent document Jan 6, 2025
About Suzhou Suncadia Biopharmaceuticals Co. Ltd.
How many FDA Form 483s has Suzhou Suncadia Biopharmaceuticals Co. Ltd. received?
FDA Intel has 3 Form 483s on file for Suzhou Suncadia Biopharmaceuticals Co. Ltd.; the most recent is dated Jan 6, 2025.
When was Suzhou Suncadia Biopharmaceuticals Co. Ltd. last inspected by FDA?
The most recent FDA inspection document on file for Suzhou Suncadia Biopharmaceuticals Co. Ltd. is a Form 483 dated Jan 6, 2025, for the site in Suzhou, China.
What did FDA cite at Suzhou Suncadia Biopharmaceuticals Co. Ltd.?
The regulations cited most in the observations on file for Suzhou Suncadia Biopharmaceuticals Co. Ltd. are 21 CFR 211.113 (Control of microbiological contamination), 6 times; 21 CFR 211.100 (Written procedures; deviations), 3 times; 21 CFR 211.160 (General requirements), 3 times.