Advanced OrthoPro, Inc
Form 483 issued July 30, 2015 · Indianapolis, Indiana
- Inspection
- Jul 27 – Jul 30, 2015
- Investigator
- Joseph R. Strelnik
- Observations
- 2
- Pages
- 2
- FEI number
- 3007912159
In short: On July 30, 2015, FDA issued a Form 483 with 2 observations to Advanced OrthoPro, Inc in Indianapolis, Indiana (FEI 3007912159) after an inspection that ran Jul 27 – Jul 30, 2015. The investigator was Joseph R. Strelnik. Most observations concern cAPA and production & process controls; the most-cited regulation is 21 CFR 820.100 (corrective and preventive action).
At a glance
CAPA and production & process controls account for 2 of 2 observations.
Most cited: 21 CFR 820.100(a) (1×) · 820.70(g)(2) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Procedures for corrective and preventive action have…
- 02
Procedures for conducting periodic inspections to ensure adherence to equipment maintenance schedules…
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 firmAdvanced OrthoPro, Inc history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 820.100(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Advanced OrthoPro, Inc?
FDA listed 2 observations on this Form 483, mostly about cAPA and production & process controls. The most-cited regulation is 21 CFR 820.100 (corrective and preventive action). The opening words of each observation are shown on this page.
Who inspected Advanced OrthoPro, Inc?
Joseph R. Strelnik is named on this Form 483, for the inspection of Jul 27 – Jul 30, 2015. Each investigator has a profile showing what they cite most.
When was Advanced OrthoPro, Inc inspected by FDA?
The inspection ran Jul 27 – Jul 30, 2015, and the Form 483 is dated July 30, 2015.
How do I get the full Form 483 for Advanced OrthoPro, 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.