Immunex Rhode Island Corporation
Form 483 issued April 19, 2019 · West Greenwich, Rhode Island
- Inspection
- Apr 15 – Apr 19, 2019
- Investigators
- Lei Zhang· William Hallett· Yetao Jin
- Observations
- 4
- Pages
- 2
- FEI number
- 3003359885
In short: On April 19, 2019, FDA issued a Form 483 with 4 observations to Immunex Rhode Island Corporation in West Greenwich, Rhode Island (FEI 3003359885) after an inspection that ran Apr 15 – Apr 19, 2019. The investigators were Lei Zhang, William Hallett, Yetao Jin, Zhihao Peter Qiu and Ziyang Su. Most observations concern quality system and laboratory controls; the most-cited regulation is 21 CFR 211.192 (production record review).
At a glance
3 of 4 observations on this 483 concern quality system.
Most cited: 21 CFR 211.192 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Inadequate procedure for investigating…
- 02
Your Quality Unit failed to provide adequate oversight to ensure instrumentation is calibrated and maintained according…
- 03
Your firm failed to…
- 04
Your Quality Unit failed to provide adequate oversight…
This inspection in context
Lei Zhang
4 documents · 2019–2025
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in Australia.
The firmImmunex Rhode Island Corporation history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.192
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Immunex Rhode Island Corporation?
FDA listed 4 observations on this Form 483, mostly about quality system and laboratory controls. The most-cited regulation is 21 CFR 211.192 (production record review). The opening words of each observation are shown on this page.
Who inspected Immunex Rhode Island Corporation?
Lei Zhang, William Hallett, Yetao Jin, Zhihao Peter Qiu and Ziyang Su are named on this Form 483, for the inspection of Apr 15 – Apr 19, 2019. Each investigator has a profile showing what they cite most.
When was Immunex Rhode Island Corporation inspected by FDA?
The inspection ran Apr 15 – Apr 19, 2019, and the Form 483 is dated April 19, 2019.
How do I get the full Form 483 for Immunex Rhode Island Corporation?
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.