Medtronic Spinal and Biologics
Form 483 issued April 9, 2009 · Sewickley, Pennsylvania
- Inspection
- Apr 7 – Apr 9, 2009
- Investigator
- Travis R. Hunt
- Observations
- 4
- Pages
- 2
- FEI number
- 3003940910
In short: On April 9, 2009, FDA issued a Form 483 with 4 observations to Medtronic Spinal and Biologics in Sewickley, Pennsylvania (FEI 3003940910) after an inspection that ran Apr 7 – Apr 9, 2009. The investigator was Travis R. Hunt. Most observations concern hCT/P; the most-cited regulation is 21 CFR 1271.160 (establishment and maintenance of a quality program).
At a glance
4 of 4 observations on this 483 concern hct/p.
What FDA observed
Preview: the opening words of each observation- 01
Procedures for the documentation ~f complaints· relating to CGTP…
- 02
The quality program has not ensured that appropriate procedures related to core CGTP. requirements were reviewed…
- 03
The quality program has not ensured that procedures include provisions for quarantine of tissues that have…
- 04
The quality program has not ensured ihat procedures exist for sharing of information pertaining to the…
This inspection in context
Travis R. Hunt
3 documents · 2008–2010
Cites 1271.160(b)(1) (establishment and maintenance of a quality program) more than any other section. Most of their documents are for sites in Pennsylvania.
The firmMedtronic Spinal and Biologics history
The site's inspection history, in date order.
Similar 483sOther sites cited under 1271.320(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Medtronic Spinal and Biologics?
FDA listed 4 observations on this Form 483, mostly about hCT/P. The most-cited regulation is 21 CFR 1271.160 (establishment and maintenance of a quality program). The opening words of each observation are shown on this page.
Who inspected Medtronic Spinal and Biologics?
Travis R. Hunt is named on this Form 483, for the inspection of Apr 7 – Apr 9, 2009. Each investigator has a profile showing what they cite most.
When was Medtronic Spinal and Biologics inspected by FDA?
The inspection ran Apr 7 – Apr 9, 2009, and the Form 483 is dated April 9, 2009.
How do I get the full Form 483 for Medtronic Spinal and Biologics?
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.