Alcon Laboratories Ireland, Ltd
Form 483 issued January 15, 2015 · Cork, Ireland
- Inspection
- Jan 12 – Jan 15, 2015
- Investigator
- Karl D. Hezel
- Observations
- 1
- Pages
- 2
- FEI number
- 3002808262
In short: On January 15, 2015, FDA issued a Form 483 with 1 observation to Alcon Laboratories Ireland, Ltd in Cork, Ireland (FEI 3002808262) after an inspection that ran Jan 12 – Jan 15, 2015. The investigator was Karl D. Hezel. Most observations concern cAPA; the most-cited regulation is 21 CFR 803.50 (if I am a manufacturer, what reporting requirements apply to me?).
At a glance
1 of 1 observations on this 483 concern capa.
Most cited: 21 CFR 803.50 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of…
This inspection in context
Karl D. Hezel
1 document · 2015
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 Ireland.
The firmAlcon Laboratories Ireland, Ltd history
The site's inspection history, in date order.
Similar 483sOther sites cited under 803.50
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Alcon Laboratories Ireland, Ltd?
FDA listed 1 observation on this Form 483, mostly about cAPA. The most-cited regulation is 21 CFR 803.50 (if I am a manufacturer, what reporting requirements apply to me?). The opening words of each observation are shown on this page.
Who inspected Alcon Laboratories Ireland, Ltd?
Karl D. Hezel is named on this Form 483, for the inspection of Jan 12 – Jan 15, 2015. Each investigator has a profile showing what they cite most.
When was Alcon Laboratories Ireland, Ltd inspected by FDA?
The inspection ran Jan 12 – Jan 15, 2015, and the Form 483 is dated January 15, 2015.
How do I get the full Form 483 for Alcon Laboratories Ireland, Ltd?
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.