Wuxi STA Pharmaceutical Co., Ltd
Form 483 issued March 3, 2023 · Wuxi, China
- Inspection
- Feb 27 – Mar 3, 2023
- Observations
- 1
- Pages
- 1
- FEI number
- 3014784835
In short: On March 3, 2023, FDA issued a Form 483 with 1 observation to Wuxi STA Pharmaceutical Co., Ltd in Wuxi, China (FEI 3014784835) after an inspection that ran Feb 27 – Mar 3, 2023. Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment).
At a glance
1 of 1 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.68 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Routine calibrations of mechanical measuring instruments are not performed…
This inspection in context
Questions about this 483
What did FDA find at Wuxi STA Pharmaceutical Co., Ltd?
FDA listed 1 observation on this Form 483, mostly about facilities & equipment. The most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment). The opening words of each observation are shown on this page.
When was Wuxi STA Pharmaceutical Co., Ltd inspected by FDA?
The inspection ran Feb 27 – Mar 3, 2023, and the Form 483 is dated March 3, 2023.
How do I get the full Form 483 for Wuxi STA Pharmaceutical 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.