Ad-Tech Medical Instrument Corporation
FDA inspection history across 2 sites, 2012 to 2019
- 2
- Warning letters
- 1
- Form 483
- 1
- Close-out
Every document, by year
- Form 483
- Close-out
- Warning letter
2012: one warning letter; 2013: one warning letter; 2014: one close-out letter; 2019: one Form 483.
The story so far
Built from the dates and citations on the documents themselves.
- 2012–14Two warning letters and one close-out letter, at Racine, Wisconsin.
- 2019One Form 483, at Oak Creek, Wisconsin.
Cited most
Across all Ad-Tech Medical Instrument observations on file
- 21 CFR 820.50Purchasing controls2
- 21 CFR 803.17(a)(2)What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?1
- 21 CFR 803.50(a)(2)If I am a manufacturer, what reporting requirements apply to me?1
- 21 CFR 820.100(a)Corrective and preventive action1
- 21 CFR 820.160(b)Distribution1
The complete Ad-Tech Medical Instrument file.
All 4 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
Racine, Wisconsin
Two warning letters and one close-out letter · 2012 to 2014
Latest: Close-out, Oct 23, 2014 →Oak Creek, Wisconsin
One Form 483 · 2019 · 12 observations
Latest: Form 483, Jun 27, 2019 →
Documents
4 on file, newest first| Date | Document | Location | Observations | Price |
|---|---|---|---|---|
| 2019-06-27 | 483 Form 483 | Oak Creek, Wisconsin | 12 | $99 |
| 2014-10-23 | Close-out Close-out letter | Racine, Wisconsin | — | $99 |
| 2013-11-14 | Warning letter Warning letter | Racine, Wisconsin | — | $99 |
| 2012-04-12 | Warning letter Warning letter | Racine, Wisconsin | — | $99 |
Investigators on these documents
FEI number 2183456 · most recent document Jun 27, 2019
About Ad-Tech Medical Instrument Corporation
How many FDA Form 483s has Ad-Tech Medical Instrument Corporation received?
FDA Intel has 1 Form 483 on file for Ad-Tech Medical Instrument Corporation; the most recent is dated Jun 27, 2019.
When was Ad-Tech Medical Instrument Corporation last inspected by FDA?
The most recent FDA inspection document on file for Ad-Tech Medical Instrument Corporation is a Form 483 dated Jun 27, 2019, for the site in Oak Creek, Wisconsin.
What did FDA cite at Ad-Tech Medical Instrument Corporation?
The regulations cited most in the observations on file for Ad-Tech Medical Instrument Corporation are 21 CFR 820.50 (Purchasing controls), 2 times; 21 CFR 803.17(a)(2) (What are the requirements for developing, maintaining, and implementing written MDR procedures that apply to me?), 1 time; 21 CFR 803.50(a)(2) (If I am a manufacturer, what reporting requirements apply to me?), 1 time.
Has Ad-Tech Medical Instrument Corporation received an FDA warning letter?
Yes. FDA Intel has 2 FDA warning letters on file for Ad-Tech Medical Instrument Corporation; the most recent is dated Nov 14, 2013.