Boston Scientific Corp
Form 483 issued May 6, 2005 · Glens Falls, New York
- Inspection
- Apr 12 – May 6, 2005
- Investigator
- Michael G. Sinkevich
- Observations
- 10
- Pages
- 6
- FEI number
- 1317056
In short: On May 6, 2005, FDA issued a Form 483 with 10 observations to Boston Scientific Corp in Glens Falls, New York (FEI 1317056) after an inspection that ran Apr 12 – May 6, 2005. The investigator was Michael G. Sinkevich. Most observations concern production & process controls and cAPA; the most-cited regulation is 21 CFR 820.80 (receiving, in-process, and finished device acceptance).
At a glance
Production & process controls and capa account for 8 of 10 observations.
Most cited: 21 CFR 820.80 (3×) · 820.198 (3×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Procedures for acceptance or rejection of incoming…
- 02
A process whose results cannot be fully verified by subsequent inspection and test has not been…
- 03
Procedures for acceptance or rejection of finished device production runs, lots, or batches were…
- 04
Acceptance procedures to ensure that specified requirements for in-process product are…
This inspection in context
Michael G. Sinkevich
1 document · 2005
Cites 820.198 (complaint files) more than any other section. Most of their documents are for sites in New York.
The firmBoston Scientific Corp history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.80
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Boston Scientific Corp?
FDA listed 10 observations on this Form 483, mostly about production & process controls, cAPA and records & documents. The most-cited regulation is 21 CFR 820.80 (receiving, in-process, and finished device acceptance). The opening words of each observation are shown on this page.
Who inspected Boston Scientific Corp?
Michael G. Sinkevich is named on this Form 483, for the inspection of Apr 12 – May 6, 2005. Each investigator has a profile showing what they cite most.
When was Boston Scientific Corp inspected by FDA?
The inspection ran Apr 12 – May 6, 2005, and the Form 483 is dated May 6, 2005.
How do I get the full Form 483 for Boston Scientific Corp?
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.