Ad-Tech Medical Instrument Corporation
Form 483 issued June 27, 2019 · Oak Creek, Wisconsin
- Inspection
- May 15 – Jun 27, 2019
- Investigator
- Michelle J. Glembin
- Observations
- 12
- Pages
- 14
- FEI number
- 2183456
In short: On June 27, 2019, FDA issued a Form 483 with 12 observations to Ad-Tech Medical Instrument Corporation in Oak Creek, Wisconsin (FEI 2183456) after an inspection that ran May 15 – Jun 27, 2019. The investigator was Michelle J. Glembin. Most observations concern cAPA and production & process controls; the most-cited regulation is 21 CFR 820.50 (purchasing controls).
At a glance
CAPA and production & process controls account for 9 of 12 observations.
What FDA observed
Preview: the opening words of each observation- 01
Products that do not conform to specifications…
- 02
Distribution records were not…
- 03
Procedures for identifying with a control number each unit, lot, or batch of implantable or life…
- 04
A device master record has…
This inspection in context
Michelle J. Glembin
5 documents · 2015–2024
Cites 820.100 (corrective and preventive action) more than any other section. Most of their documents are for sites in Wisconsin.
The firmAd-Tech Medical Instrument Corporation history
All 4 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 820.90(a)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Ad-Tech Medical Instrument Corporation?
FDA listed 12 observations on this Form 483, mostly about cAPA, production & process controls and records & documents. The most-cited regulation is 21 CFR 820.50 (purchasing controls). The opening words of each observation are shown on this page.
Who inspected Ad-Tech Medical Instrument Corporation?
Michelle J. Glembin is named on this Form 483, for the inspection of May 15 – Jun 27, 2019. Each investigator has a profile showing what they cite most.
When was Ad-Tech Medical Instrument Corporation inspected by FDA?
The inspection ran May 15 – Jun 27, 2019, and the Form 483 is dated June 27, 2019.
How do I get the full Form 483 for Ad-Tech Medical Instrument Corporation?
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.