Boston Scientific Corporation
Form 483 issued August 26, 2005 · Natick, Massachusetts
- Inspection
- Jul 27 – Aug 26, 2005
- Observations
- 7
- Pages
- 6
- FEI number
- 3000204642
In short: On August 26, 2005, FDA issued a Form 483 with 7 observations to Boston Scientific Corporation in Natick, Massachusetts (FEI 3000204642) after an inspection that ran Jul 27 – Aug 26, 2005. Most observations concern cAPA and management controls; the most-cited regulation is 21 CFR 820.20 (management responsibility).
At a glance
5 of 7 observations on this 483 concern capa.
Most cited: 21 CFR 820.20 (2×) · 803.50 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Management with executive responsibility has not ensured that an adequate and effective quality system has been…
- 02
Employees who manage, perform, and assess work affecting quality have not been provided the independence and…
- 03
A correction or removal, conducted to reduce a risk to health posed by a device, was…
- 04
An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of…
This inspection in context
Questions about this 483
What did FDA find at Boston Scientific Corporation?
FDA listed 7 observations on this Form 483, mostly about cAPA and management controls. The most-cited regulation is 21 CFR 820.20 (management responsibility). The opening words of each observation are shown on this page.
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.