Invacare Corporation
Form 483 issued December 9, 2015 · Elyria, Ohio
- Inspection
- Dec 9, 2015
- Investigators
- Benjamin Dastoli· Laureen M. Geniusz
- Observations
- 6
- Pages
- 13
- FEI number
- 3002889431
In short: On December 9, 2015, FDA issued a Form 483 with 6 observations to Invacare Corporation in Elyria, Ohio (FEI 3002889431) after an inspection that ran Dec 9, 2015. The investigators were Benjamin Dastoli and Laureen M. Geniusz. 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 5 of 6 observations.
What FDA observed
Preview: the opening words of each observation- 01n/a
Deviation from the procedural requirements of…
- 02
Design verification does not confirm that design output…
- 03
Observation 3: scanned text, readable in the full document.
- 04
Design input requirements were not adequately documented, Design input requirements…
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 firmInvacare 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 820.30(f)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Invacare Corporation?
FDA listed 6 observations on this Form 483, mostly about design controls and production & process 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 Invacare Corporation?
Benjamin Dastoli and Laureen M. Geniusz are named on this Form 483, for the inspection of Dec 9, 2015. Each investigator has a profile showing what they cite most.
When was Invacare Corporation inspected by FDA?
The inspection ran Dec 9, 2015, and the Form 483 is dated December 9, 2015.
How do I get the full Form 483 for Invacare 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.