Carbogen Amcis AG
Form 483 issued December 16, 2022 · Bubendorf, Switzerland
- Inspection
- Dec 8 – Dec 16, 2022
- Investigator
- Edmund F. Mrak Jr
- Observations
- 2
- Pages
- 2
- FEI number
- 3000998501
In short: On December 16, 2022, FDA issued a Form 483 with 2 observations to Carbogen Amcis AG in Bubendorf, Switzerland (FEI 3000998501) after an inspection that ran Dec 8 – Dec 16, 2022. The investigator was Edmund F. Mrak Jr. Most observations concern laboratory controls and production; the most-cited regulation is 21 CFR 211.113 (control of microbiological contamination).
At a glance
Laboratory controls and production account for 2 of 2 observations.
Most cited: 21 CFR 211.194 (1×) · 211.113 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
You do not review complete data derived from all laboratory tests conducted to ensure that critical…
- 02
Your firm fails to demonstrate that water used in” of API manufacture and cleaning production equipment…
This inspection in context
Edmund F. Mrak Jr
7 documents · 2012–2022
Cites 211.160 (general requirements) more than any other section. Most of their documents are for sites in Massachusetts.
The firmCarbogen Amcis AG history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.194
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Carbogen Amcis AG?
FDA listed 2 observations on this Form 483, mostly about laboratory controls and production. The most-cited regulation is 21 CFR 211.113 (control of microbiological contamination). The opening words of each observation are shown on this page.
Who inspected Carbogen Amcis AG?
Edmund F. Mrak Jr is named on this Form 483, for the inspection of Dec 8 – Dec 16, 2022. Each investigator has a profile showing what they cite most.
When was Carbogen Amcis AG inspected by FDA?
The inspection ran Dec 8 – Dec 16, 2022, and the Form 483 is dated December 16, 2022.
How do I get the full Form 483 for Carbogen Amcis AG?
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.