Boston Scientific Corporation
Form 483 issued May 20, 2005 · Quincy, Massachusetts
- Inspection
- Mar 28, 2005 – Apr 8, 2008
- Investigator
- Darin S. Wiegers
- Observations
- 15
- Pages
- 10
- FEI number
- 3001451463
In short: On May 20, 2005, FDA issued a Form 483 with 15 observations to Boston Scientific Corporation in Quincy, Massachusetts (FEI 3001451463) after an inspection that ran Mar 28, 2005 – Apr 8, 2008. The investigator was Darin S. Wiegers. Most observations concern cAPA and management controls; the most-cited regulation is 21 CFR 820.100 (corrective and preventive action).
At a glance
CAPA and management controls account for 11 of 15 observations.
Most cited: 21 CFR 820.100 (5×) · 820.90 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
The organization structure is not adequate to assure that quality system…
- 02
Products that do not conform to specifications…
- 03
There is no documentation of the…
- 04
Corrective and preventive action activities have not been documented, including investigations of causes of nonconformities, the…
This inspection in context
Darin S. Wiegers
1 document · 2005
Cites 820.100 (corrective and preventive action) more than any other section. Most of their documents are for sites in Massachusetts.
The firmBoston Scientific Corporation history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.100
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Boston Scientific Corporation?
FDA listed 15 observations on this Form 483, mostly about cAPA, management controls and records & documents. The most-cited regulation is 21 CFR 820.100 (corrective and preventive action). The opening words of each observation are shown on this page.
Who inspected Boston Scientific Corporation?
Darin S. Wiegers is named on this Form 483, for the inspection of Mar 28, 2005 – Apr 8, 2008. Each investigator has a profile showing what they cite most.
When was Boston Scientific Corporation inspected by FDA?
The inspection ran Mar 28, 2005 – Apr 8, 2008, and the Form 483 is dated May 20, 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.