SpineNet LLC
FDA inspection history in Winter Park, Florida, 2013 to 2019
- 1
- Form 483
- 1
- Warning letter
Every document, by year
- Form 483
- Warning letter
2013: one warning letter; 2019: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2013One warning letter, at Winter Park, Florida.
- 2019One Form 483, at Winter Park, Florida.
Cited most
Across all SpineNet observations on file
- 21 CFR 820.30(c)Design controls2
- 21 CFR 820.22Quality audit1
The complete SpineNet 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
Winter Park, Florida
One Form 483 and one warning letter · 2013 to 2019 · 3 observations
Latest: Form 483, Oct 9, 2019 →
Documents
2 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2019-10-09 | 483 Form 483 | Winter Park, Florida | 3 | $99 |
| 2013-05-31 | Warning letter Warning letter | Winter Park, Florida | — | $99 |
Investigators on these documents
FEI number 3006755626 · most recent document Oct 9, 2019
About SpineNet LLC
How many FDA Form 483s has SpineNet LLC received?
FDA Intel has 1 Form 483 on file for SpineNet LLC; the most recent is dated Oct 9, 2019.
When was SpineNet LLC last inspected by FDA?
The most recent FDA inspection document on file for SpineNet LLC is a Form 483 dated Oct 9, 2019, for the site in Winter Park, Florida.
What did FDA cite at SpineNet LLC?
The regulations cited most in the observations on file for SpineNet LLC are 21 CFR 820.30(c) (Design controls), 2 times; 21 CFR 820.22 (Quality audit), 1 time.
Has SpineNet LLC received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for SpineNet LLC; the most recent is dated May 31, 2013.