Invacare Corporation
Form 483 issued August 18, 2010 · Sanford, Florida
- Inspection
- Aug 2 – Aug 18, 2010
- Investigators
- Andrea H. Norwood· Richard K. Vogel
- Observations
- 10
- Pages
- 12
- FEI number
- 1031452
In short: On August 18, 2010, FDA issued a Form 483 with 10 observations to Invacare Corporation in Sanford, Florida (FEI 1031452) after an inspection that ran Aug 2 – Aug 18, 2010. The investigators were Andrea H. Norwood and Richard K. Vogel. Most observations concern cAPA and design controls; the most-cited regulation is 21 CFR 820.100 (corrective and preventive action).
At a glance
CAPA and design controls account for 7 of 10 observations.
Most cited: 21 CFR 820.100(b) (2×) · 820.30(g) (2×)
What FDA observed
Preview: the opening words of each observation- 01
Corrective and preventive action activities and/or results…
- 02
Complaints involving the possible failure of a device and labeling to meet any of its specifications…
- 03
Risk analysis is…
- 04
Requirements that must be met by suppliers and contractors have…
This inspection in context
Andrea H. Norwood
2 documents · 2010
Cites 803.50 (if i am a manufacturer, what reporting requirements apply to me?) more than any other section. Most of their documents are for sites in Florida.
The firmInvacare Corporation history
All 10 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 820.100(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Invacare Corporation?
FDA listed 10 observations on this Form 483, mostly about cAPA, design controls and management controls. The most-cited regulation is 21 CFR 820.100 (corrective and preventive action). The opening words of each observation are shown on this page.
Who inspected Invacare Corporation?
Andrea H. Norwood and Richard K. Vogel are named on this Form 483, for the inspection of Aug 2 – Aug 18, 2010. Each investigator has a profile showing what they cite most.
When was Invacare Corporation inspected by FDA?
The inspection ran Aug 2 – Aug 18, 2010, and the Form 483 is dated August 18, 2010.
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.