Alphatec Spine, Inc.
Form 483 issued April 19, 2017 · Carlsbad, California
- Inspection
- Apr 3 – Apr 19, 2017
- Investigator
- Shaquenta Y. Perkins
- Observations
- 1
- Pages
- 3
- FEI number
- 2027467
In short: On April 19, 2017, FDA issued a Form 483 with 1 observation to Alphatec Spine, Inc. in Carlsbad, California (FEI 2027467) after an inspection that ran Apr 3 – Apr 19, 2017. The investigator was Shaquenta Y. Perkins. Most observations concern design controls; the most-cited regulation is 21 CFR 820.30 (design controls).
At a glance
1 of 1 observations on this 483 concern design controls.
Most cited: 21 CFR 820.30(g) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Risk analysis is…
This inspection in context
Shaquenta Y. Perkins
5 documents · 2015–2018
Cites 820.100 (corrective and preventive action) more than any other section. Most of their documents are for sites in California.
The firmAlphatec Spine, Inc. history
All 7 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 820.30(g)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Alphatec Spine, Inc.?
FDA listed 1 observation on this Form 483, mostly about design controls. The most-cited regulation is 21 CFR 820.30 (design controls). The opening words of each observation are shown on this page.
Who inspected Alphatec Spine, Inc.?
Shaquenta Y. Perkins is named on this Form 483, for the inspection of Apr 3 – Apr 19, 2017. Each investigator has a profile showing what they cite most.
When was Alphatec Spine, Inc. inspected by FDA?
The inspection ran Apr 3 – Apr 19, 2017, and the Form 483 is dated April 19, 2017.
How do I get the full Form 483 for Alphatec Spine, Inc.?
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.