Innovative Sterilization Technologies
Form 483 issued November 4, 2015 · Dayton, Ohio
- Inspection
- Oct 6 – Nov 4, 2015
- Investigators
- Rosanna M. Goodrich· Shannon A. Gregory
- Observations
- 4
- Pages
- 4
- FEI number
- 3010772758
In short: On November 4, 2015, FDA issued a Form 483 with 4 observations to Innovative Sterilization Technologies in Dayton, Ohio (FEI 3010772758) after an inspection that ran Oct 6 – Nov 4, 2015. The investigators were Rosanna M. Goodrich and Shannon A. Gregory. Most observations concern design controls and production & process controls; the most-cited regulation is 21 CFR 820.30 (design controls).
At a glance
Design controls and production & process controls account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observation- 01
Procedures for design control…
- 02
Procedures for design change have…
- 03
Procedures for changes to a process…
- 04
EMPLOYEEfS) SIGNATURE twins Document control procedures have, not…
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(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Innovative Sterilization Technologies?
FDA listed 4 observations on this Form 483, mostly about design controls, production & process controls and records & documents. 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 Oct 6 – Nov 4, 2015. Each investigator has a profile showing what they cite most.
When was Innovative Sterilization Technologies inspected by FDA?
The inspection ran Oct 6 – Nov 4, 2015, and the Form 483 is dated November 4, 2015.
How do I get the full Form 483 for Innovative Sterilization Technologies?
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