Innovative Sterilization Technologies
Form 483 issued January 13, 2022 · Dayton, Ohio
- Inspection
- Dec 13, 2021 – Jan 13, 2022
- Investigators
- Rosanna M. Goodrich· Shannon A. Gregory
- Observations
- 2
- Pages
- 5
- FEI number
- 3010772758
In short: On January 13, 2022, FDA issued a Form 483 with 2 observations to Innovative Sterilization Technologies in Dayton, Ohio (FEI 3010772758) after an inspection that ran Dec 13, 2021 – Jan 13, 2022. The investigators were Rosanna M. Goodrich and Shannon A. Gregory. Most observations concern design controls; the most-cited regulation is 21 CFR 820.30 (design controls).
At a glance
2 of 2 observations on this 483 concern design controls.
Most cited: 21 CFR 820.30(g) (1×) · 820.30(i) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Risk analysis is…
- 02
Procedures for design change have…
This inspection in context
Rosanna M. Goodrich
13 documents · 2015–2025
Cites 820.100(a) (corrective and preventive action) more than any other section. Most of their documents are for sites in Ohio.
The firmInnovative Sterilization Technologies history
All 4 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 820.30(g)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Innovative Sterilization Technologies?
FDA listed 2 observations on this Form 483, mostly about design controls. The most-cited regulation is 21 CFR 820.30 (design controls). The opening words of each observation are shown on this page.
Who inspected Innovative Sterilization Technologies?
Rosanna M. Goodrich and Shannon A. Gregory are named on this Form 483, for the inspection of Dec 13, 2021 – Jan 13, 2022. Each investigator has a profile showing what they cite most.
When was Innovative Sterilization Technologies inspected by FDA?
The inspection ran Dec 13, 2021 – Jan 13, 2022, and the Form 483 is dated January 13, 2022.
How do I get the full Form 483 for Innovative Sterilization Technologies?
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