CooperVision Inc.
FDA inspection history across 2 sites, 2011
- 1
- Warning letter
- 1
- Form 483
Every document, by year
- Warning letter
- Form 483
2011: one warning letter and one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2011One warning letter and one Form 483, at Pleasanton, California and W Henri e tta, New York.
Cited most
Across all CooperVision observations on file
- 21 CFR 820.100(a)Corrective and preventive action1
- 21 CFR 820.184Device history record1
- 21 CFR 820.198(c)Complaint files1
- 21 CFR 820.75(a)Process validation1
- 21 CFR 820.80(d)Receiving, in-process, and finished device acceptance1
The complete CooperVision file.
All 2 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Pleasanton, California
One warning letter · 2011
Latest: Warning letter, Dec 5, 2011 →W Henri e tta, New York
One Form 483 · 2011 · 5 observations
Latest: Form 483, Oct 24, 2011 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2011-12-05 | Warning letter Warning letter | Pleasanton, California | — | $99 |
| 2011-10-24 | 483 Form 483 | W Henri e tta, New York | 5 | $99 |
Investigators on these documents
FEI number 3005724763 · most recent document Dec 5, 2011
About CooperVision Inc.
How many FDA Form 483s has CooperVision Inc. received?
FDA Intel has 1 Form 483 on file for CooperVision Inc.; the most recent is dated Oct 24, 2011.
When was CooperVision Inc. last inspected by FDA?
The most recent FDA inspection document on file for CooperVision Inc. is a Form 483 dated Oct 24, 2011, for the site in W Henri e tta, New York.
What did FDA cite at CooperVision Inc.?
The regulations cited most in the observations on file for CooperVision Inc. are 21 CFR 820.100(a) (Corrective and preventive action), 1 time; 21 CFR 820.184 (Device history record), 1 time; 21 CFR 820.198(c) (Complaint files), 1 time.
Has CooperVision Inc. received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for CooperVision Inc.; the most recent is dated Dec 5, 2011.