CooperVision Inc.
Form 483 issued October 24, 2011 · W Henri e tta, New York
- Inspection
- Oct 14 – Oct 24, 2011
- Investigator
- Marc S. Neubauer
- Observations
- 5
- Pages
- 4
- FEI number
- 3005724763
In short: On October 24, 2011, FDA issued a Form 483 with 5 observations to CooperVision Inc. in W Henri e tta, New York (FEI 3005724763) after an inspection that ran Oct 14 – Oct 24, 2011. The investigator was Marc S. Neubauer. Most observations concern production & process controls and cAPA.
At a glance
Production & process controls and capa account for 4 of 5 observations.
What FDA observed
Preview: the opening words of each observation- 01
A process whose results cannot be fully verified by subsequent inspection and test has not been…
- 02
Procedures for finished device acceptance…
- 03
Procedures for device history records…
- 04
Procedures for corrective and preventive action have…
This inspection in context
Marc S. Neubauer
3 documents · 2011–2017
Cites 820.100(a) (corrective and preventive action) more than any other section. Most of their documents are for sites in Maryland.
The firmCooperVision Inc. history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 820.75(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at CooperVision Inc.?
FDA listed 5 observations on this Form 483, mostly about production & process controls, cAPA and records & documents. The opening words of each observation are shown on this page.
Who inspected CooperVision Inc.?
Marc S. Neubauer is named on this Form 483, for the inspection of Oct 14 – Oct 24, 2011. Each investigator has a profile showing what they cite most.
When was CooperVision Inc. inspected by FDA?
The inspection ran Oct 14 – Oct 24, 2011, and the Form 483 is dated October 24, 2011.
How do I get the full Form 483 for CooperVision Inc.?
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.