Medtronic Puerto Rico Operations Company
Form 483 issued March 10, 2010 · Juncos, Puerto Rico
- Inspection
- Dec 10, 2009 – Mar 10, 2010
- Investigators
- Gonzalez Pizarro· Marilyn Santiago
- Observations
- 6
- Pages
- 7
- FEI number
- 3004369318
In short: On March 10, 2010, FDA issued a Form 483 with 6 observations to Medtronic Puerto Rico Operations Company in Juncos, Puerto Rico (FEI 3004369318) after an inspection that ran Dec 10, 2009 – Mar 10, 2010. The investigators were Gonzalez Pizarro and Marilyn Santiago. Most observations concern cAPA; the most-cited regulation is 21 CFR 820.198 (complaint files).
At a glance
6 of 6 observations on this 483 concern capa.
Most cited: 21 CFR 820.198 (4×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Complaints representing events that are MDR reportable were not promptly reviewed, evaluated, and investigated…
- 02
Not all of the actions needed to correct and prevent the recurrence of nonconforming product and…
- 03
Complaints involving the possible failure of a device to meet any of its specifications were…
- 04
Records of complaint investigations do not include the…
This inspection in context
Gonzalez Pizarro
1 document · 2010
Cites 820.198 (complaint files) more than any other section. Most of their documents are for sites in Puerto Rico.
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 820.198
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 6 observations on this Form 483, mostly about cAPA. The most-cited regulation is 21 CFR 820.198 (complaint files). The opening words of each observation are shown on this page.
Who inspected Medtronic Puerto Rico Operations Company?
Gonzalez Pizarro and Marilyn Santiago are named on this Form 483, for the inspection of Dec 10, 2009 – Mar 10, 2010. Each investigator has a profile showing what they cite most.
When was Medtronic Puerto Rico Operations Company inspected by FDA?
The inspection ran Dec 10, 2009 – Mar 10, 2010, and the Form 483 is dated March 10, 2010.
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.