Suzhou Suncadia Biopharmaceuticals Co. Ltd.
Form 483 issued December 14, 2023 · Suzhou, China
- Inspection
- Nov 30 – Dec 14, 2023
- Investigator
- Yiwei Li
- Observations
- 10
- Pages
- 10
- FEI number
- 3015786877
In short: On December 14, 2023, FDA issued a Form 483 with 10 observations to Suzhou Suncadia Biopharmaceuticals Co. Ltd. in Suzhou, Jiangsu (FEI 3015786877) after an inspection that ran Nov 30 – Dec 14, 2023. The investigator was Yiwei Li. Most observations concern production and laboratory controls; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Production and laboratory controls account for 6 of 10 observations.
Most cited: 21 CFR 211.113 (3×) · 211.160 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The drug product manufacturing process and procedures do not support frequent high-risk interventions to aseptic processing…
- 02
Your firm has not established adequate procedural controls over equipment systems to ensure data…
- 03
Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are…
- 04
The responsibilities and procedures applicable to the quality unit are not in…
This inspection in context
Yiwei Li
7 documents · 2023–2025
Cites 211.160 (general requirements) 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 10 observations on this Form 483, mostly about production, laboratory controls and quality system. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected Suzhou Suncadia Biopharmaceuticals Co. Ltd.?
Yiwei Li is named on this Form 483, for the inspection of Nov 30 – Dec 14, 2023. Each investigator has a profile showing what they cite most.
When was Suzhou Suncadia Biopharmaceuticals Co. Ltd. inspected by FDA?
The inspection ran Nov 30 – Dec 14, 2023, and the Form 483 is dated December 14, 2023.
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.