Alphatec Spine, Inc.
Form 483 issued March 13, 2015 · Carlsbad, California
- Inspection
- Feb 4 – Mar 13, 2015
- Investigator
- Scott K. Zika
- Observations
- 9
- Pages
- 7
- FEI number
- 2027467
In short: On March 13, 2015, FDA issued a Form 483 with 9 observations to Alphatec Spine, Inc. in Carlsbad, California (FEI 2027467) after an inspection that ran Feb 4 – Mar 13, 2015. The investigator was Scott K. Zika.
What FDA observed
Preview: the opening words of each observation- 01
An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of…
- 02
The design was not validated under actual…
- 03
The design history file…
- 04
A device history record has…
This inspection in context
Scott K. Zika
7 documents · 2009–2018
Cites 803.50 (if i am a manufacturer, what reporting requirements apply to me?) 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.
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Questions about this 483
What did FDA find at Alphatec Spine, Inc.?
FDA listed 9 observations on this Form 483. The opening words of each observation are shown on this page.
Who inspected Alphatec Spine, Inc.?
Scott K. Zika is named on this Form 483, for the inspection of Feb 4 – Mar 13, 2015. Each investigator has a profile showing what they cite most.
When was Alphatec Spine, Inc. inspected by FDA?
The inspection ran Feb 4 – Mar 13, 2015, and the Form 483 is dated March 13, 2015.
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.