Advanced OrthoPro, Inc
FDA inspection history in Indianapolis, Indiana, 2012 to 2015
- 1
- Close-out
- 1
- Form 483
- 1
- Warning letter
Every document, by year
- Close-out
- Form 483
- Warning letter
2012: one warning letter; 2015: one close-out letter and one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2012One warning letter, at Indianapolis, Indiana.
- 2015One close-out letter and one Form 483, at Indianapolis, Indiana.
Cited most
Across all Advanced OrthoPro observations on file
- 21 CFR 820.100(a)Corrective and preventive action1
- 21 CFR 820.70(g)(2)Production and process controls1
The complete Advanced OrthoPro file.
All 3 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.
The price of the documents, added to your cart together
Sites
Indianapolis, Indiana
One close-out letter, one Form 483 and one warning letter · 2012 to 2015 · 2 observations
Latest: Close-out, Dec 1, 2015 →
Documents
3 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2015-12-01 | Close-out Close-out letter | Indianapolis, Indiana | — | $99 |
| 2015-07-30 | 483 Form 483 | Indianapolis, Indiana | 2 | $99 |
| 2012-05-18 | Warning letter Warning letter | Indianapolis, Indiana | — | $99 |
Investigators on these documents
FEI number 3007912159 · most recent document Dec 1, 2015
About Advanced OrthoPro, Inc
How many FDA Form 483s has Advanced OrthoPro, Inc received?
FDA Intel has 1 Form 483 on file for Advanced OrthoPro, Inc; the most recent is dated Jul 30, 2015.
When was Advanced OrthoPro, Inc last inspected by FDA?
The most recent FDA inspection document on file for Advanced OrthoPro, Inc is a Form 483 dated Jul 30, 2015, for the site in Indianapolis, Indiana.
What did FDA cite at Advanced OrthoPro, Inc?
The regulations cited most in the observations on file for Advanced OrthoPro, Inc are 21 CFR 820.100(a) (Corrective and preventive action), 1 time; 21 CFR 820.70(g)(2) (Production and process controls), 1 time.
Has Advanced OrthoPro, Inc received an FDA warning letter?
Yes. FDA Intel has 1 FDA warning letter on file for Advanced OrthoPro, Inc; the most recent is dated May 18, 2012.