Trokamed GmbH
Form 483 issued February 19, 2016 · Geisingen, Germany
- Inspection
- Feb 15 – Feb 19, 2016
- Investigator
- James R. Montero
- Observations
- 1
- Pages
- 3
- FEI number
- 3004595684
In short: On February 19, 2016, FDA issued a Form 483 with 1 observation to Trokamed GmbH in Geisingen, Germany (FEI 3004595684) after an inspection that ran Feb 15 – Feb 19, 2016. The investigator was James R. Montero. Most observations concern cAPA; the most-cited regulation is 21 CFR 820.100 (corrective and preventive action).
At a glance
1 of 1 observations on this 483 concern capa.
Most cited: 21 CFR 820.100(b) (1×)
What FDA observed
Preview: the opening words of each observation- 01
Corrective and preventive action activities and/or results have…
This inspection in context
James R. Montero
10 documents · 2014–2025
Cites 820.100 (corrective and preventive action) more than any other section. Most of their documents are for sites in Utah.
The firmTrokamed GmbH 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(b)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Trokamed GmbH?
FDA listed 1 observation on this Form 483, mostly about cAPA. 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 Trokamed GmbH?
James R. Montero is named on this Form 483, for the inspection of Feb 15 – Feb 19, 2016. Each investigator has a profile showing what they cite most.
When was Trokamed GmbH inspected by FDA?
The inspection ran Feb 15 – Feb 19, 2016, and the Form 483 is dated February 19, 2016.
How do I get the full Form 483 for Trokamed GmbH?
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.