FDA Intel

Alphatec Spine, Inc.

Form 483 issued February 11, 2010 · Carlsbad, California

Inspection
Jan 20 – Feb 11, 2010
Investigator
Scott K. Zika
Observations
11
Pages
6
FEI number
2027467

In short: On February 11, 2010, FDA issued a Form 483 with 11 observations to Alphatec Spine, Inc. in Carlsbad, California (FEI 2027467) after an inspection that ran Jan 20 – Feb 11, 2010. The investigator was Scott K. Zika. Most observations concern cAPA and production & process controls; the most-cited regulation is 21 CFR 803.50 (if I am a manufacturer, what reporting requirements apply to me?).

At a glance

7 of 11 observations on this 483 concern capa.

CAPA7
Production & process controls3
Design controls1

Most cited: 21 CFR 820.75(a) (2×)

What FDA observed

Preview: the opening words of each observation
  1. 01
    21 CFR 803.52(f)(1)

    An individual medical device manufacturer report submitted per FDA Form 3500A did not indicate in Block…

  2. 02
    21 CFR 803.50(a)(1)

    An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of…

  3. 03
    21 CFR 803.50(a)(2)

    An MDR report was not submitted within 30 days of receiving or otherwise becoming aware of…

  4. 04
    21 CFR 820.30(d)

    Design outputs that are essential for the proper functioning of the device…

7 more observations

Plus the full detail behind each one, exactly as FDA wrote it.

Get the full 483

This inspection in context

The investigator

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 firm

Alphatec Spine, Inc. history

All 7 documents on file for this site, in date order, with what was cited at each inspection.

Similar 483s

Other sites cited under 820.75(a)

See how FDA wrote the same problem up elsewhere.

Questions about this 483

What did FDA find at Alphatec Spine, Inc.?

FDA listed 11 observations on this Form 483, mostly about cAPA, production & process controls and design controls. The most-cited regulation is 21 CFR 803.50 (if I am a manufacturer, what reporting requirements apply to me?). 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 Jan 20 – Feb 11, 2010. Each investigator has a profile showing what they cite most.

When was Alphatec Spine, Inc. inspected by FDA?

The inspection ran Jan 20 – Feb 11, 2010, and the Form 483 is dated February 11, 2010.

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.

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