Spectranetics Corporation
Form 483 issued January 21, 2016 · Colorado Springs, Colorado
- Inspection
- Nov 30, 2015 – Jan 21, 2016
- Investigator
- Christine I. Shaw
- Observations
- 10
- Pages
- 14
- FEI number
- 3007284006
In short: On January 21, 2016, FDA issued a Form 483 with 10 observations to Spectranetics Corporation in Colorado Springs, Colorado (FEI 3007284006) after an inspection that ran Nov 30, 2015 – Jan 21, 2016. The investigator was Christine I. Shaw. Most observations concern design controls and cAPA; the most-cited regulation is 21 CFR 820.30 (design controls).
At a glance
Observations span 4 systems, led by design controls.
Most cited: 21 CFR 820.30 (2×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
A process whose results cannot be fully verified by subsequent inspection and test has not been…
- 02
Design input requirements were…
- 03
An MDR report was no : submitted avithin 30 days of receiving or otherwise becoming aware…
- 04
Observation 4: scanned text, readable in the full document.
This inspection in context
Christine I. Shaw
8 documents · 2016–2022
Cites 820.30 (design controls) more than any other section. Most of their documents are for sites in Colorado.
The firmSpectranetics 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 820.30
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Spectranetics Corporation?
FDA listed 10 observations on this Form 483, mostly about design controls, cAPA and production & process controls. The most-cited regulation is 21 CFR 820.30 (design controls). The opening words of each observation are shown on this page.
Who inspected Spectranetics Corporation?
Christine I. Shaw is named on this Form 483, for the inspection of Nov 30, 2015 – Jan 21, 2016. Each investigator has a profile showing what they cite most.
When was Spectranetics Corporation inspected by FDA?
The inspection ran Nov 30, 2015 – Jan 21, 2016, and the Form 483 is dated January 21, 2016.
How do I get the full Form 483 for Spectranetics 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.