Cooper Vision Caribbean
Form 483 issued April 25, 2008 · Juana Diaz, Maryland
- Inspection
- Apr 21 – Apr 25, 2008
- Investigator
- Noreen Muniz
- Observations
- 3
- Pages
- 4
- FEI number
- 3002911336
In short: On April 25, 2008, FDA issued a Form 483 with 3 observations to Cooper Vision Caribbean in Juana Diaz, Maryland (FEI 3002911336) after an inspection that ran Apr 21 – Apr 25, 2008. The investigator was Noreen Muniz. Most observations concern cAPA and production & process controls.
At a glance
2 of 3 observations on this 483 concern capa.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Process validation activities and results have…
- 02
Complete complaint files are…
- 03
The procedures for implementing corrective and preventive…
This inspection in context
Noreen Muniz
24 documents · 2008–2022
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in Puerto Rico.
The firmCooper Vision Caribbean history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 820.75
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Cooper Vision Caribbean?
FDA listed 3 observations on this Form 483, mostly about cAPA and production & process controls. The opening words of each observation are shown on this page.
Who inspected Cooper Vision Caribbean?
Noreen Muniz is named on this Form 483, for the inspection of Apr 21 – Apr 25, 2008. Each investigator has a profile showing what they cite most.
When was Cooper Vision Caribbean inspected by FDA?
The inspection ran Apr 21 – Apr 25, 2008, and the Form 483 is dated April 25, 2008.
How do I get the full Form 483 for Cooper Vision Caribbean?
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.