Spectranetics Corporation
FDA inspection history across 2 sites, 2016 to 2019
- 1
- Close-out
- 1
- Form 483
Every document, by year
- Close-out
- Form 483
2016: one Form 483; 2019: one close-out letter.
The story so far
Built from the dates and citations on the documents themselves.
- 2016One Form 483, at Colorado Springs, Colorado.
- 2019One close-out letter, at San Diego, California.
Cited most
Across all Spectranetics observations on file
- 21 CFR 820.30Design controls2
- 21 CFR 1002.20Reporting of accidental radiation occurrences1
- 21 CFR 1003.20Notification by the manufacturer to the Secretary1
- 21 CFR 1010.2Certification1
- 21 CFR 1040.10Laser products1
The complete Spectranetics file.
All 2 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
San Diego, California
One close-out letter · 2019
Latest: Close-out, May 16, 2019 →Colorado Springs, Colorado
One Form 483 · 2016 · 10 observations
Latest: Form 483, Jan 21, 2016 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2019-05-16 | Close-out Close-out letter | San Diego, California | — | $99 |
| 2016-01-21 | 483 Form 483 | Colorado Springs, Colorado | 10 | $99 |
Investigators on these documents
FEI number 3007284006 · most recent document May 16, 2019
About Spectranetics Corporation
How many FDA Form 483s has Spectranetics Corporation received?
FDA Intel has 1 Form 483 on file for Spectranetics Corporation; the most recent is dated Jan 21, 2016.
When was Spectranetics Corporation last inspected by FDA?
The most recent FDA inspection document on file for Spectranetics Corporation is a Form 483 dated Jan 21, 2016, for the site in Colorado Springs, Colorado.
What did FDA cite at Spectranetics Corporation?
The regulations cited most in the observations on file for Spectranetics Corporation are 21 CFR 820.30 (Design controls), 2 times; 21 CFR 1002.20 (Reporting of accidental radiation occurrences), 1 time; 21 CFR 1003.20 (Notification by the manufacturer to the Secretary), 1 time.