Boston Scientific Corporation
Form 483 issued July 15, 2015 · Spencer, Indiana
- Inspection
- Jun 29 – Jul 15, 2015
- Investigator
- Joseph R. Strelnik
- Observations
- 1
- Pages
- 2
- FEI number
- 1828132
In short: On July 15, 2015, FDA issued a Form 483 with 1 observation to Boston Scientific Corporation in Spencer, Indiana (FEI 1828132) after an inspection that ran Jun 29 – Jul 15, 2015. The investigator was Joseph R. Strelnik. Most observations concern production & process controls; the most-cited regulation is 21 CFR 820.70 (production and process controls).
At a glance
1 of 1 observations on this 483 concern production & process controls.
Most cited: 21 CFR 820.70(c) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Procedures to control environmental conditions have…
This inspection in context
Joseph R. Strelnik
13 documents · 2011–2022
Cites 820.30 (design controls) more than any other section. Most of their documents are for sites in Indiana.
The firmBoston Scientific Corporation history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 820.70(c)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Boston Scientific Corporation?
FDA listed 1 observation on this Form 483, mostly about production & process controls. The most-cited regulation is 21 CFR 820.70 (production and process controls). The opening words of each observation are shown on this page.
Who inspected Boston Scientific Corporation?
Joseph R. Strelnik is named on this Form 483, for the inspection of Jun 29 – Jul 15, 2015. Each investigator has a profile showing what they cite most.
When was Boston Scientific Corporation inspected by FDA?
The inspection ran Jun 29 – Jul 15, 2015, and the Form 483 is dated July 15, 2015.
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.