In short: On May 9, 2023, FDA issued a Form 483 with 7 observations to WuXi Biologics Co. Ltd. in Wuxi, Jiangsu (FEI 3010606982) after an inspection that ran Apr 24 – May 9, 2023. The investigators were Bo Chi and Jun Liu. Most observations concern production and quality system; the most-cited regulation is 21 CFR 211.100 (written procedures; deviations).
At a glance
Observations span 4 systems, led by production.
Most cited: 21 CFR 211.100 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The Qua lity Un…
- 02
The visua l inspection program for 6 4…
- 03
Observation 3: scanned text, readable in the full document.
- 04
Observation 4: scanned text, readable in the full document.
This inspection in context
Bo Chi
8 documents · 2013–2024
Cites 211.100 (written procedures; deviations) more than any other section. Most of their documents are for sites in California.
The firmWuXi Biologics Co. Ltd. history
All 4 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.100
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at WuXi Biologics Co. Ltd.?
FDA listed 7 observations on this Form 483, mostly about production, quality system and laboratory controls. The most-cited regulation is 21 CFR 211.100 (written procedures; deviations). The opening words of each observation are shown on this page.
Who inspected WuXi Biologics Co. Ltd.?
Bo Chi and Jun Liu are named on this Form 483, for the inspection of Apr 24 – May 9, 2023. Each investigator has a profile showing what they cite most.
When was WuXi Biologics Co. Ltd. inspected by FDA?
The inspection ran Apr 24 – May 9, 2023, and the Form 483 is dated May 9, 2023.
How do I get the full Form 483 for WuXi Biologics 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.