WuXi Biologics Co. Ltd.
Form 483 issued April 2, 2021 · Mashan, China
- Inspection
- Mar 22 – Apr 2, 2021
- Investigator
- Jonathan W. Chapman
- Observations
- 2
- Pages
- 5
- FEI number
- 3010606982
In short: On April 2, 2021, FDA issued a Form 483 with 2 observations to WuXi Biologics Co. Ltd. in Mashan, China (FEI 3010606982) after an inspection that ran Mar 22 – Apr 2, 2021. The investigator was Jonathan W. Chapman. Most observations concern facilities & equipment and quality system; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
Facilities & equipment and quality system account for 2 of 2 observations.
Most cited: 21 CFR 211.68 (1×) · 211.22 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Appropriate controls are not exercised over computer systems or related systems to…
- 02
The Quality Unit oversight over the issuance of…
This inspection in context
Jonathan W. Chapman
11 documents · 2014–2021
Cites 211.100 (written procedures; deviations) more than any other section. Most of their documents are for sites in China.
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 211.68
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at WuXi Biologics Co. Ltd.?
FDA listed 2 observations on this Form 483, mostly about facilities & equipment and quality system. The most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit). The opening words of each observation are shown on this page.
Who inspected WuXi Biologics Co. Ltd.?
Jonathan W. Chapman is named on this Form 483, for the inspection of Mar 22 – Apr 2, 2021. Each investigator has a profile showing what they cite most.
When was WuXi Biologics Co. Ltd. inspected by FDA?
The inspection ran Mar 22 – Apr 2, 2021, and the Form 483 is dated April 2, 2021.
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.