Theken Spine LLC
FDA inspection history in A kron, Ohio, 2010
- 1
- Form 483
Every document, by year
- Form 483
2010: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2010One Form 483, at A kron, Ohio.
Cited most
Across all Theken Spine observations on file
- 21 CFR 803.50(a)(2)If I am a manufacturer, what reporting requirements apply to me?1
- 21 CFR 820.100(b)Corrective and preventive action1
- 21 CFR 820.75(a)Process validation1
The complete Theken Spine file.
All 1 documents as original PDFs. For supplier audits, diligence and inspection prep.
Sites
A kron, Ohio
One Form 483 · 2010 · 3 observations
Latest: Form 483, Jul 2, 2010 →
Documents
1 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2010-07-02 | 483 Form 483 | A kron, Ohio | 3 | $99 |
Investigators on these documents
FEI number 3002498892 · most recent document Jul 2, 2010
About Theken Spine LLC
How many FDA Form 483s has Theken Spine LLC received?
FDA Intel has 1 Form 483 on file for Theken Spine LLC; the most recent is dated Jul 2, 2010.
When was Theken Spine LLC last inspected by FDA?
The most recent FDA inspection document on file for Theken Spine LLC is a Form 483 dated Jul 2, 2010, for the site in A kron, Ohio.
What did FDA cite at Theken Spine LLC?
The regulations cited most in the observations on file for Theken Spine LLC are 21 CFR 803.50(a)(2) (If I am a manufacturer, what reporting requirements apply to me?), 1 time; 21 CFR 820.100(b) (Corrective and preventive action), 1 time; 21 CFR 820.75(a) (Process validation), 1 time.