Medtronic Puerto Rico Operations Company
Form 483 issued April 28, 2016 · Juncos, Puerto Rico
- Inspection
- Apr 5 – Apr 28, 2016
- Investigator
- Laiza V. Garcia
- Observations
- 3
- Pages
- 6
- FEI number
- 3004369318
In short: On April 28, 2016, FDA issued a Form 483 with 3 observations to Medtronic Puerto Rico Operations Company in Juncos, Puerto Rico (FEI 3004369318) after an inspection that ran Apr 5 – Apr 28, 2016. The investigator was Laiza V. Garcia. Most observations concern production & process controls and cAPA.
At a glance
2 of 3 observations on this 483 concern production & process controls.
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures for monitoring and control of process parameters for a validated process have not been adequately…
- 02
Procedures for the acceptance of in-process product have not been adequately established. EMPLQYEEfSi SIGNATURE A. Procedures…
- 03
Corrective and preventive action activities and/or results have not been adequately documented. CAPA activities conducted by…
This inspection in context
Laiza V. Garcia
5 documents · 2015–2019
Cites 820.100 (corrective and preventive action) 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 820.75
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 3 observations on this Form 483, mostly about production & process controls and cAPA. The opening words of each observation are shown on this page.
Who inspected Medtronic Puerto Rico Operations Company?
Laiza V. Garcia is named on this Form 483, for the inspection of Apr 5 – Apr 28, 2016. Each investigator has a profile showing what they cite most.
When was Medtronic Puerto Rico Operations Company inspected by FDA?
The inspection ran Apr 5 – Apr 28, 2016, and the Form 483 is dated April 28, 2016.
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.