Theken Spine LLC
Form 483 issued July 2, 2010 · A kron, Ohio
- Inspection
- Jun 14 – Jul 2, 2010
- Investigators
- Benjamin Dastoli· Michael E. Campbell
- Observations
- 3
- Pages
- 5
- FEI number
- 3002498892
In short: On July 2, 2010, FDA issued a Form 483 with 3 observations to Theken Spine LLC in A kron, Ohio (FEI 3002498892) after an inspection that ran Jun 14 – Jul 2, 2010. The investigators were Benjamin Dastoli and Michael E. Campbell. Most observations concern cAPA and production & process controls.
At a glance
2 of 3 observations on this 483 concern capa.
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
A process whose results cannot be fully verified by subsequent inspection and test has not been…
- 03
Corrective and preventive action activities and/or results…
This inspection in context
Benjamin Dastoli
12 documents · 2009–2023
Cites 820.75 (process validation) more than any other section. Most of their documents are for sites in Ohio.
The firmTheken Spine LLC history
The site's inspection history, in date order.
Similar 483sOther sites cited under 803.50(a)(2)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Theken Spine LLC?
FDA listed 3 observations on this Form 483, mostly about cAPA and production & process controls. The opening words of each observation are shown on this page.
Who inspected Theken Spine LLC?
Benjamin Dastoli and Michael E. Campbell are named on this Form 483, for the inspection of Jun 14 – Jul 2, 2010. Each investigator has a profile showing what they cite most.
When was Theken Spine LLC inspected by FDA?
The inspection ran Jun 14 – Jul 2, 2010, and the Form 483 is dated July 2, 2010.
How do I get the full Form 483 for Theken Spine LLC?
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.