Boston Scientific Corporation
Form 483 issued January 11, 2017 · Fremont, California
- Inspection
- Dec 15, 2016 – Jan 11, 2017
- Investigator
- Adam S. Freeman
- Observations
- 3
- Pages
- 4
- FEI number
- 2939204
In short: On January 11, 2017, FDA issued a Form 483 with 3 observations to Boston Scientific Corporation in Fremont, California (FEI 2939204) after an inspection that ran Dec 15, 2016 – Jan 11, 2017. The investigator was Adam S. Freeman. Most observations concern cAPA.
At a glance
3 of 3 observations on this 483 concern capa.
What FDA observed
Preview: the opening words of each observation- 01
A correction or removal, conducted to reduce a risk to health posed by a device, was…
- 02
Procedures for corrective and preventive action have…
- 03
Complaints involving the possible failure of a device to meet any of its specifications were…
This inspection in context
Adam S. Freeman
2 documents · 2016–2017
Cites 806.10(a)(1) (reports of corrections and removals) more than any other section. Most of their documents are for sites in California.
The firmBoston Scientific Corporation history
The site's inspection history, in date order.
Similar 483sOther sites cited under 806.10(a)(1)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Boston Scientific Corporation?
FDA listed 3 observations on this Form 483, mostly about cAPA. The opening words of each observation are shown on this page.
Who inspected Boston Scientific Corporation?
Adam S. Freeman is named on this Form 483, for the inspection of Dec 15, 2016 – Jan 11, 2017. Each investigator has a profile showing what they cite most.
When was Boston Scientific Corporation inspected by FDA?
The inspection ran Dec 15, 2016 – Jan 11, 2017, and the Form 483 is dated January 11, 2017.
How do I get the full Form 483 for Boston Scientific Corporation?
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.