Invacare Corporation
FDA inspection history across 2 sites, 2003 to 2011
- 5
- Responses
- 3
- Warning letters
- 1
- Form 483
Every document, by year
- Response
- Warning letter
- Form 483
2003: one warning letter; 2010: one warning letter, one 483 response and one Form 483; 2011: four warning letter responses, one fda_correspondence and one warning letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2003One warning letter, at Elyria, Ohio.
- 2010–11Four warning letter responses, two warning letters, one 483 response, one Form 483 and one fda_correspondence, at Elyria, Ohio and Sanford, Florida.
Cited most
Across all Invacare observations on file
- 21 CFR 803.50If I am a manufacturer, what reporting requirements apply to me?2
- 21 CFR 820.100(b)Corrective and preventive action2
- 21 CFR 820.25(a)Personnel2
- 21 CFR 820.30(g)Design controls2
- 21 CFR 820.198(c)Complaint files1
The complete Invacare file.
All 9 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
15% off buying them one by one
Sites
Elyria, Ohio
Four warning letter responses, three warning letters, one fda_correspondence and one 483 response · 2003 to 2011
Latest: Response, Jun 10, 2011 →Sanford, Florida
One Form 483 · 2010 · 10 observations
Latest: Form 483, Aug 18, 2010 →
Documents
10 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2011-06-10 | Response Warning letter response | Elyria, Ohio | — | $199 |
| 2011-05-13 | fda_correspondence FDA document | Elyria, Ohio | — | — |
| 2011-04-29 | Warning letter Warning letter | Elyria, Ohio | — | $99 |
| 2011-03-18 | Response Warning letter response | Elyria, Ohio | — | $199 |
| 2011-02-18 | Response Warning letter response | Elyria, Ohio | — | $199 |
| 2011-01-11 | Response Warning letter response | Elyria, Ohio | — | $199 |
| 2010-12-15 | Warning letter Warning letter | Elyria, Ohio | — | $99 |
| 2010-09-08 | Response 483 response | Elyria, Ohio | — | $199 |
| 2010-08-18 | 483 Form 483 | Sanford, Florida | 10 | $99 |
| 2003-08-26 | Warning letter Warning letter | Elyria, Ohio | — | $99 |
Investigators on these documents
FEI number 1031452 · most recent document Jun 10, 2011
About Invacare Corporation
How many FDA Form 483s has Invacare Corporation received?
FDA Intel has 1 Form 483 on file for Invacare Corporation; the most recent is dated Aug 18, 2010.
When was Invacare Corporation last inspected by FDA?
The most recent FDA inspection document on file for Invacare Corporation is a Form 483 dated Aug 18, 2010, for the site in Sanford, Florida.
What did FDA cite at Invacare Corporation?
The regulations cited most in the observations on file for Invacare Corporation are 21 CFR 803.50 (If I am a manufacturer, what reporting requirements apply to me?), 2 times; 21 CFR 820.100(b) (Corrective and preventive action), 2 times; 21 CFR 820.25(a) (Personnel), 2 times.
Has Invacare Corporation received an FDA warning letter?
Yes. FDA Intel has 3 FDA warning letters on file for Invacare Corporation; the most recent is dated Apr 29, 2011.