WuXi Biologics Co. Ltd.
Form 483 issued April 16, 2020 · Wuxi, China
- Inspection
- Apr 8, 2019 – Apr 16, 2020
- Investigators
- Christopher T. Middendorf· Mekonnen Lemma Dechassa· Ramesh Potla
- Observations
- 4
- Pages
- 3
- FEI number
- 3010606982
In short: On April 16, 2020, FDA issued a Form 483 with 4 observations to WuXi Biologics Co. Ltd. in Wuxi, China (FEI 3010606982) after an inspection that ran Apr 8, 2019 – Apr 16, 2020. The investigators were Christopher T. Middendorf, Mekonnen Lemma Dechassa and Ramesh Potla. Most observations concern quality system and laboratory controls; the most-cited regulation is 21 CFR 211.22 (responsibilities of quality control unit).
At a glance
Quality system and laboratory controls account for 4 of 4 observations.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The responsibilities and procedures applicable to the quality control unit for material suppliers are…
- 02
Corrective actions are not taken when data from critical quality attributes indicate a trend towards…
- 03
The amount of samples sufficient to perform all tests, except for endotoxin and sterility, in…
- 04
All information to ensure method accuracy, reproducibility, and reliability, is not included in analytical method evaluation…
This inspection in context
Christopher T. Middendorf
8 documents · 2011–2020
Cites 211.160 (general requirements) 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 211.22
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at WuXi Biologics Co. Ltd.?
FDA listed 4 observations on this Form 483, mostly about quality system and laboratory controls. 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.?
Christopher T. Middendorf, Mekonnen Lemma Dechassa and Ramesh Potla are named on this Form 483, for the inspection of Apr 8, 2019 – Apr 16, 2020. Each investigator has a profile showing what they cite most.
When was WuXi Biologics Co. Ltd. inspected by FDA?
The inspection ran Apr 8, 2019 – Apr 16, 2020, and the Form 483 is dated April 16, 2020.
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.