Alphatec Spine, Inc.
FDA inspection history in Carlsbad, California, 2009 to 2017
- 3
- Form 483s
- 2
- Warning letters
- 2
- EIRs
Every document, by year
- Form 483
- Warning letter
- EIR
2009: one inspection report; 2010: one warning letter, one Form 483 and one inspection report; 2011: one warning letter; 2015: one Form 483; 2017: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2009–11Two inspection reports, two warning letters and one Form 483, at Carlsbad, California.
- 2010The longest 483 on file: 11 observations over 6 pages at Carlsbad, California.
- 2015–17Two Form 483s, at Carlsbad, California.
Cited most
Across all Alphatec Spine observations on file
- 21 CFR 803.50(a)(1)If I am a manufacturer, what reporting requirements apply to me?2
- 21 CFR 820.100(a)Corrective and preventive action2
- 21 CFR 820.30(d)Design controls2
- 21 CFR 820.75(a)Process validation2
- 21 CFR 803.52(f)(1)If I am a manufacturer, what information must I submit in my individual adverse event reports?1
The complete Alphatec Spine file.
All 7 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
15% off buying them one by one
Sites
Carlsbad, California
Three Form 483s, two warning letters and two inspection reports · 2009 to 2017 · 21 observations
Latest: Form 483, Apr 19, 2017 →
Documents
7 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2017-04-19 | 483 Form 483 | Carlsbad, California | 1 | $99 |
| 2015-03-13 | 483 Form 483 | Carlsbad, California | 9 | $99 |
| 2011-01-11 | Warning letter Warning letter | Carlsbad, California | — | $99 |
| 2010-06-21 | Warning letter Warning letter | Carlsbad, California | — | $99 |
| 2010-02-11 | 483 Form 483 | Carlsbad, California | 11 | $99 |
| 2010-02-11 | EIR EIR | Carlsbad, California | — | $550 |
| 2009-05-18 | EIR EIR | Carlsbad, California | — | $550 |
Investigators on these documents
Scott K. Zika (4)Shaquenta Y. Perkins (1)Virgilio F. Pacio (1)
FEI number 2027467 · most recent document Apr 19, 2017
About Alphatec Spine, Inc.
How many FDA Form 483s has Alphatec Spine, Inc. received?
FDA Intel has 3 Form 483s on file for Alphatec Spine, Inc.; the most recent is dated Apr 19, 2017.
When was Alphatec Spine, Inc. last inspected by FDA?
The most recent FDA inspection document on file for Alphatec Spine, Inc. is a Form 483 dated Apr 19, 2017, for the site in Carlsbad, California.
What did FDA cite at Alphatec Spine, Inc.?
The regulations cited most in the observations on file for Alphatec Spine, Inc. are 21 CFR 803.50(a)(1) (If I am a manufacturer, what reporting requirements apply to me?), 2 times; 21 CFR 820.100(a) (Corrective and preventive action), 2 times; 21 CFR 820.30(d) (Design controls), 2 times.
Has Alphatec Spine, Inc. received an FDA warning letter?
Yes. FDA Intel has 2 FDA warning letters on file for Alphatec Spine, Inc.; the most recent is dated Jan 11, 2011.