Roche Diagnostics Operations, Inc
Form 483 issued August 15, 2016 · Indianapolis, Indiana
- Inspection
- Aug 4 – Aug 15, 2016
- Investigators
- Joseph R. Strelnik· Kennita Riddick
- Observations
- 1
- Pages
- 3
- FEI number
- 1823260
In short: On August 15, 2016, FDA issued a Form 483 with 1 observation to Roche Diagnostics Operations, Inc in Indianapolis, Indiana (FEI 1823260) after an inspection that ran Aug 4 – Aug 15, 2016. The investigators were Joseph R. Strelnik and Kennita Riddick. Most observations concern cAPA; the most-cited regulation is 21 CFR 806.10 (reports of corrections and removals).
At a glance
1 of 1 observations on this 483 concern capa.
Most cited: 21 CFR 806.10(a)(1) (1×)
What FDA observed
Preview: the opening words of each observation- 01
A correction or removal, conducted to reduce a risk to health posed by a device, was…
This inspection in context
Joseph R. Strelnik
13 documents · 2011–2022
Cites 820.30 (design controls) more than any other section. Most of their documents are for sites in Indiana.
The firmRoche Diagnostics Operations, Inc history
The site's inspection history, in date order.
Similar 483sOther sites cited under 806.10(a)(1)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Roche Diagnostics Operations, Inc?
FDA listed 1 observation on this Form 483, mostly about cAPA. The most-cited regulation is 21 CFR 806.10 (reports of corrections and removals). The opening words of each observation are shown on this page.
Who inspected Roche Diagnostics Operations, Inc?
Joseph R. Strelnik and Kennita Riddick are named on this Form 483, for the inspection of Aug 4 – Aug 15, 2016. Each investigator has a profile showing what they cite most.
When was Roche Diagnostics Operations, Inc inspected by FDA?
The inspection ran Aug 4 – Aug 15, 2016, and the Form 483 is dated August 15, 2016.
How do I get the full Form 483 for Roche Diagnostics Operations, 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.