Boston Scientifc Corporation
Form 483 issued April 7, 2005 · Watertown, Massachusetts
- Inspection
- Mar 9 – Apr 7, 2005
- Investigator
- Carla C. Cummins
- Observations
- 9
- Pages
- 7
- FEI number
- 1219544
In short: On April 7, 2005, FDA issued a Form 483 with 9 observations to Boston Scientifc Corporation in Watertown, Massachusetts (FEI 1219544) after an inspection that ran Mar 9 – Apr 7, 2005. The investigator was Carla C. Cummins. Most observations concern cAPA and production & process controls; the most-cited regulation is 21 CFR 820.75 (process validation).
At a glance
CAPA and production & process controls account for 6 of 9 observations.
Most cited: 21 CFR 820.75 (2×) · 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
Not all of the actions needed to correct and prevent the recurrence of nonconforming product and…
- 02
The acceptance status of product was not clearly identified throughout installation and…
- 03
A process whose results cannot be fully verified by subsequent inspection and test has not been…
- 04
A validated process was not revalidated when changes…
This inspection in context
Carla C. Cummins
1 document · 2005
Cites 820.75 (process validation) more than any other section. Most of their documents are for sites in Massachusetts.
The firmBoston Scientifc Corporation history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.75
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Boston Scientifc Corporation?
FDA listed 9 observations on this Form 483, mostly about cAPA, production & process controls and management controls. The most-cited regulation is 21 CFR 820.75 (process validation). The opening words of each observation are shown on this page.
Who inspected Boston Scientifc Corporation?
Carla C. Cummins is named on this Form 483, for the inspection of Mar 9 – Apr 7, 2005. Each investigator has a profile showing what they cite most.
When was Boston Scientifc Corporation inspected by FDA?
The inspection ran Mar 9 – Apr 7, 2005, and the Form 483 is dated April 7, 2005.
How do I get the full Form 483 for Boston Scientifc 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.