Medtronic Puerto Rico Operations Co. Rd 909 Km 0.4
Form 483 issued May 31, 2019 · Humacao, Puerto Rico
- Inspection
- May 13 – May 31, 2019
- Investigator
- Nydia E. Colon
- Observations
- 1
- Pages
- 6
- FEI number
- 2647346
In short: On May 31, 2019, FDA issued a Form 483 with 1 observation to Medtronic Puerto Rico Operations Co. Rd 909 Km 0.4 in Humacao, Puerto Rico (FEI 2647346) after an inspection that ran May 13 – May 31, 2019. The investigator was Nydia E. Colon. 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…
This inspection in context
Nydia E. Colon
4 documents · 2019–2024
Cites 820.100(a) (corrective and preventive action) more than any other section. Most of their documents are for sites in Puerto Rico.
The firmMedtronic Puerto Rico Operations Co. Rd 909 Km 0.4 history
The site's inspection history, in date order.
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 Co. Rd 909 Km 0.4?
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 Co. Rd 909 Km 0.4?
Nydia E. Colon is named on this Form 483, for the inspection of May 13 – May 31, 2019. Each investigator has a profile showing what they cite most.
When was Medtronic Puerto Rico Operations Co. Rd 909 Km 0.4 inspected by FDA?
The inspection ran May 13 – May 31, 2019, and the Form 483 is dated May 31, 2019.
How do I get the full Form 483 for Medtronic Puerto Rico Operations Co. Rd 909 Km 0.4?
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.