Immunex Rhode Island Corporation
Form 483 issued December 7, 2021 · West Greenwich, Rhode Island
- Investigators
- Jacek Cieslak· Leiyun Boone· Richard Ledwidge
- Observations
- 4
- Pages
- 2
- FEI number
- 3003359885
In short: On December 7, 2021, FDA issued a Form 483 with 4 observations to Immunex Rhode Island Corporation in West Greenwich, Rhode Island (FEI 3003359885). The investigators were Jacek Cieslak, Leiyun Boone and Richard Ledwidge. Most observations concern laboratory controls and facilities & equipment; the most-cited regulation is 21 CFR 211.160 (general requirements).
At a glance
Laboratory controls and facilities & equipment account for 3 of 4 observations.
Most cited: 21 CFR 211.160 (2×) · 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
Your firm lacks procedural control to ensure that incoming…
- 02
Your cleaning procedures for…
- 03
Facility equipment is not…
- 04
Standard operating procedures are…
This inspection in context
Jacek Cieslak
6 documents · 2019–2023
Cites 211.100 (written procedures; deviations) more than any other section. Most of their documents are for sites in Japan.
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 211.160
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 laboratory controls and facilities & equipment. The most-cited regulation is 21 CFR 211.160 (general requirements). The opening words of each observation are shown on this page.
Who inspected Immunex Rhode Island Corporation?
Jacek Cieslak, Leiyun Boone and Richard Ledwidge are named on this Form 483. Each investigator has a profile showing what they cite most.
When was Immunex Rhode Island Corporation inspected by FDA?
This Form 483 is dated December 7, 2021.
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.