Herbamed AG
Form 483 issued September 14, 2023 · Buehler, Switzerland
- Inspection
- Sep 11 – Sep 14, 2023
- Investigator
- Carl A. Huffman Iii
- Observations
- 3
- Pages
- 1
- FEI number
- 1000343707
In short: On September 14, 2023, FDA issued a Form 483 with 3 observations to Herbamed AG in Buehler, Appenzell Ausserrhoden (FEI 1000343707) after an inspection that ran Sep 11 – Sep 14, 2023. The investigator was Carl A. Huffman Iii. Most observations concern quality system and laboratory controls; the most-cited regulation is 21 CFR 211.180 (general requirements).
At a glance
Quality system and laboratory controls account for 2 of 3 observations.
Most cited: 21 CFR 211.180 (1×) · 211.166 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Product Quality Reviews (PQRs)…
- 02
You have not performed stability testing on 2 for lot 2 which was shipped to the…
- 03
You are not closing out change controls…
This inspection in context
Carl A. Huffman Iii
3 documents · 2010–2023
Cites 211.166 (stability testing) more than any other section. Most of their documents are for sites in Illinois.
The firmHerbamed AG history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.180
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Herbamed AG?
FDA listed 3 observations on this Form 483, mostly about quality system and laboratory controls. The most-cited regulation is 21 CFR 211.180 (general requirements). The opening words of each observation are shown on this page.
Who inspected Herbamed AG?
Carl A. Huffman Iii is named on this Form 483, for the inspection of Sep 11 – Sep 14, 2023. Each investigator has a profile showing what they cite most.
When was Herbamed AG inspected by FDA?
The inspection ran Sep 11 – Sep 14, 2023, and the Form 483 is dated September 14, 2023.
How do I get the full Form 483 for Herbamed 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.