Steris Isomedix Services
Form 483 issued December 3, 2015 · Libertyville, Illinois
- Inspection
- Sep 25 – Dec 3, 2015
- Observations
- 1
- Pages
- 2
- FEI number
- 3003015552
In short: On December 3, 2015, FDA issued a Form 483 with 1 observation to Steris Isomedix Services in Libertyville, Illinois (FEI 3003015552) after an inspection that ran Sep 25 – Dec 3, 2015. Most observations concern production & process controls; the most-cited regulation is 21 CFR 820.70 (production and process controls).
At a glance
1 of 1 observations on this 483 concern production & process controls.
Most cited: 21 CFR 820.70(a) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Production processes were not conducted to ensure that a device…
This inspection in context
Questions about this 483
What did FDA find at Steris Isomedix Services?
FDA listed 1 observation on this Form 483, mostly about production & process controls. The most-cited regulation is 21 CFR 820.70 (production and process controls). The opening words of each observation are shown on this page.
When was Steris Isomedix Services inspected by FDA?
The inspection ran Sep 25 – Dec 3, 2015, and the Form 483 is dated December 3, 2015.
How do I get the full Form 483 for Steris Isomedix Services?
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.