Spineology, Inc
FDA inspection history in Saint Paul, Minnesota, 2010 to 2022
- 2
- Form 483s
- 1
- Close-out
- 1
- Warning letter
Every document, by year
- Form 483
- Close-out
- Warning letter
2010: one close-out letter and one warning letter; 2017: one Form 483; 2022: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2010One close-out letter and one warning letter, at Saint Paul, Minnesota.
- 2017One Form 483, at Saint Paul, Minnesota.
- 2017The longest 483 on file: 5 observations over 2 pages at Saint Paul, Minnesota.
- 2022One Form 483, at Saint Paul, Minnesota.
Cited most
Across all Spineology observations on file
- 21 CFR 820.30(g)Design controls2
- 21 CFR 820.100(a)Corrective and preventive action1
- 21 CFR 820.150Storage1
- 21 CFR 820.184Device history record1
- 21 CFR 820.70(i)Production and process controls1
The complete Spineology file.
All 4 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
Saint Paul, Minnesota
Two Form 483s, one close-out letter and one warning letter · 2010 to 2022 · 7 observations
Latest: Form 483, Feb 15, 2022 →
Documents
4 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2022-02-15 | 483 Form 483 | Saint Paul, Minnesota | 2 | $99 |
| 2017-03-31 | 483 Form 483 | Saint Paul, Minnesota | 5 | $99 |
| 2010-09-22 | Close-out Close-out letter | Saint Paul, Minnesota | — | $99 |
| 2010-09-22 | Warning letter Warning letter | Saint Paul, Minnesota | — | $99 |
Investigators on these documents
Albert L. Nguyen (1)Christina L. Bigham (1)Susan M. Matthias (1)
FEI number 3003179719 · most recent document Feb 15, 2022
About Spineology, Inc
How many FDA Form 483s has Spineology, Inc received?
FDA Intel has 2 Form 483s on file for Spineology, Inc; the most recent is dated Feb 15, 2022.
When was Spineology, Inc last inspected by FDA?
The most recent FDA inspection document on file for Spineology, Inc is a Form 483 dated Feb 15, 2022, for the site in Saint Paul, Minnesota.
What did FDA cite at Spineology, Inc?
The regulations cited most in the observations on file for Spineology, Inc are 21 CFR 820.30(g) (Design controls), 2 times; 21 CFR 820.100(a) (Corrective and preventive action), 1 time; 21 CFR 820.150 (Storage), 1 time.
Has Spineology, Inc received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Spineology, Inc; the most recent is dated Sep 22, 2010.