Boston Scientific Corporation
Form 483 issued August 26, 2005 · Stoneham, Massachusetts
- Inspection
- Jul 27 – Aug 26, 2005
- Investigator
- John J. Kiley
- Observations
- 3
- Pages
- 6
- FEI number
- 3000204642
In short: On August 26, 2005, FDA issued a Form 483 with 3 observations to Boston Scientific Corporation in Stoneham, Massachusetts (FEI 3000204642) after an inspection that ran Jul 27 – Aug 26, 2005. The investigator was John J. Kiley. Most observations concern cAPA; the most-cited regulation is 21 CFR 820.198 (complaint files).
At a glance
1 of 1 observations on this 483 concern capa.
Most cited: 21 CFR 820.198 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Complaint handling pmeedutes have nut been established w ensure that all~ are~ in…
This inspection in context
John J. Kiley
1 document · 2005
Cites 820.198 (complaint files) more than any other section. Most of their documents are for sites in Massachusetts.
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 3 observations on this Form 483, mostly about cAPA. 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?
John J. Kiley is named on this Form 483, for the inspection of Jul 27 – Aug 26, 2005. Each investigator has a profile showing what they cite most.
When was Boston Scientific Corporation inspected by FDA?
The inspection ran Jul 27 – Aug 26, 2005, and the Form 483 is dated August 26, 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.