Medtronic Spinal and Biologics
FDA inspection history in Sewickley, Pennsylvania, 2009
- 1
- Form 483
Every document, by year
- Form 483
2009: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2009One Form 483, at Sewickley, Pennsylvania.
Cited most
Across all Medtronic Spinal and Biologics observations on file
- 21 CFR 1271.160(b)(1)Establishment and maintenance of a quality program3
- 21 CFR 1271.320(a)Complaint file1
The complete Medtronic Spinal and Biologics file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
Sewickley, Pennsylvania
One Form 483 · 2009 · 4 observations
Latest: Form 483, Apr 9, 2009 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2009-04-09 | 483 Form 483 | Sewickley, Pennsylvania | 4 | $99 |
Investigators on these documents
FEI number 3003940910 · most recent document Apr 9, 2009
About Medtronic Spinal and Biologics
How many FDA Form 483s has Medtronic Spinal and Biologics received?
FDA Intel has 1 Form 483 on file for Medtronic Spinal and Biologics; the most recent is dated Apr 9, 2009.
When was Medtronic Spinal and Biologics last inspected by FDA?
The most recent FDA inspection document on file for Medtronic Spinal and Biologics is a Form 483 dated Apr 9, 2009, for the site in Sewickley, Pennsylvania.
What did FDA cite at Medtronic Spinal and Biologics?
The regulations cited most in the observations on file for Medtronic Spinal and Biologics are 21 CFR 1271.160(b)(1) (Establishment and maintenance of a quality program), 3 times; 21 CFR 1271.320(a) (Complaint file), 1 time.