Boston Scientific Corporation
Form 483 issued September 12, 2005 · Spencer, Indiana
- Inspection
- Aug 25 – Sep 12, 2005
- Investigator
- Benjamin J. Smith
- Observations
- 4
- Pages
- 3
- FEI number
- 1828132
In short: On September 12, 2005, FDA issued a Form 483 with 4 observations to Boston Scientific Corporation in Spencer, Indiana (FEI 1828132) after an inspection that ran Aug 25 – Sep 12, 2005. The investigator was Benjamin J. Smith. Most observations concern cAPA and production & process controls; the most-cited regulation is 21 CFR 820.198 (complaint files).
At a glance
3 of 4 observations on this 483 concern capa.
Most cited: 21 CFR 820.198 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
An MDR report was not submitted within 30 days of receiving or otherwise becoming aware ofinformation…
- 02
Complaints involving the possible failure of a device to meet any of its specifications were not…
- 03
Complaint handling procedures for reviewing and evaluating complaints…
- 04
Procedures for the control and distribution of finished devices have not been defmed and complete to…
This inspection in context
Benjamin J. Smith
1 document · 2005
Cites 820.198 (complaint files) 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 820.198
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Boston Scientific Corporation?
FDA listed 4 observations on this Form 483, mostly about cAPA and production & process controls. The most-cited regulation is 21 CFR 820.198 (complaint files). The opening words of each observation are shown on this page.
Who inspected Boston Scientific Corporation?
Benjamin J. Smith is named on this Form 483, for the inspection of Aug 25 – Sep 12, 2005. Each investigator has a profile showing what they cite most.
When was Boston Scientific Corporation inspected by FDA?
The inspection ran Aug 25 – Sep 12, 2005, and the Form 483 is dated September 12, 2005.
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.