Covidien
Form 483 issued August 27, 2014 · Ponce, Puerto Rico
- Inspection
- Jul 23 – Aug 27, 2014
- Investigator
- Miguel G. Manzano Maldonado
- Observations
- 2
- Pages
- 3
- FEI number
- 2647580
In short: On August 27, 2014, FDA issued a Form 483 with 2 observations to Covidien in Ponce, Puerto Rico (FEI 2647580) after an inspection that ran Jul 23 – Aug 27, 2014. The investigator was Miguel G. Manzano Maldonado. 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
2 of 2 observations on this 483 concern capa.
Most cited: 21 CFR 803.50(a)(2) (1×) · 820.100(a) (1×)
What FDA observed
Preview: the opening words of each observation- 01
An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of…
- 02
Procedures for corrective and preventive action have…
This inspection in context
Miguel G. Manzano Maldonado
1 document · 2014
Cites 803.50(a)(2) (if i am a manufacturer, what reporting requirements apply to me?) more than any other section. Most of their documents are for sites in Puerto Rico.
The firmCovidien history
The site's inspection history, in date order.
Similar 483sOther sites cited under 803.50(a)(2)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Covidien?
FDA listed 2 observations 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 Covidien?
Miguel G. Manzano Maldonado is named on this Form 483, for the inspection of Jul 23 – Aug 27, 2014. Each investigator has a profile showing what they cite most.
When was Covidien inspected by FDA?
The inspection ran Jul 23 – Aug 27, 2014, and the Form 483 is dated August 27, 2014.
How do I get the full Form 483 for Covidien?
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.