Medtronic Puerto Rico Operations Company
Form 483 issued October 25, 2019 · Juncos, Puerto Rico
- Inspection
- Oct 1 – Oct 25, 2019
- Investigators
- Dianiris C. Ayala· Laiza V. Garcia· Monica C. Burgos Garcia
- Observations
- 1
- Pages
- 10
- FEI number
- 3004369318
In short: On October 25, 2019, FDA issued a Form 483 with 1 observation to Medtronic Puerto Rico Operations Company in Juncos, Puerto Rico (FEI 3004369318) after an inspection that ran Oct 1 – Oct 25, 2019. The investigators were Dianiris C. Ayala, Laiza V. Garcia and Monica C. Burgos Garcia. Most observations concern cAPA; the most-cited regulation is 21 CFR 820.100 (corrective and preventive action).
At a glance
1 of 1 observations on this 483 concern capa.
Most cited: 21 CFR 820.100(a) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Procedures for corrective and preventive action have not been adequately established. A. Investigations conceming corrective and…
This inspection in context
Dianiris C. Ayala
8 documents · 2009–2024
Cites 820.100 (corrective and preventive action) more than any other section. Most of their documents are for sites in Florida.
The firmMedtronic Puerto Rico Operations Company history
All 6 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 820.100(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Medtronic Puerto Rico Operations Company?
FDA listed 1 observation on this Form 483, mostly about cAPA. The most-cited regulation is 21 CFR 820.100 (corrective and preventive action). The opening words of each observation are shown on this page.
Who inspected Medtronic Puerto Rico Operations Company?
Dianiris C. Ayala, Laiza V. Garcia and Monica C. Burgos Garcia are named on this Form 483, for the inspection of Oct 1 – Oct 25, 2019. Each investigator has a profile showing what they cite most.
When was Medtronic Puerto Rico Operations Company inspected by FDA?
The inspection ran Oct 1 – Oct 25, 2019, and the Form 483 is dated October 25, 2019.
How do I get the full Form 483 for Medtronic Puerto Rico Operations Company?
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.