Innovative Medical Equipment
Form 483 issued March 10, 2022 · Beachwood, Ohio
- Inspection
- Mar 3 – Mar 10, 2022
- Investigator
- Benjamin Dastoli
- Observations
- 4
- Pages
- 6
- FEI number
- 3007353136
In short: On March 10, 2022, FDA issued a Form 483 with 4 observations to Innovative Medical Equipment in Beachwood, Ohio (FEI 3007353136) after an inspection that ran Mar 3 – Mar 10, 2022. The investigator was Benjamin Dastoli. 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
Risk analysis is…
- 02
Procedures to ensure that all purchased or otherwise received product and services conform to specified requirements…
- 03
Procedures for corrective and preventive action…
- 04
Procedures for design verification have…
This inspection in context
Benjamin Dastoli
12 documents · 2009–2023
Cites 820.75 (process validation) more than any other section. Most of their documents are for sites in Ohio.
The firmInnovative Medical Equipment history
The site's inspection history, in date order.
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 Medical Equipment?
FDA listed 4 observations on this Form 483, mostly about design controls, production & process controls and cAPA. 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 Medical Equipment?
Benjamin Dastoli is named on this Form 483, for the inspection of Mar 3 – Mar 10, 2022. Each investigator has a profile showing what they cite most.
When was Innovative Medical Equipment inspected by FDA?
The inspection ran Mar 3 – Mar 10, 2022, and the Form 483 is dated March 10, 2022.
How do I get the full Form 483 for Innovative Medical Equipment?
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.