Boehringer Ingelheim RCV GmbH & Co KG
Form 483 issued December 5, 2023 · Vienna, Austria
- Inspection
- Nov 29 – Dec 5, 2023
- Investigator
- Prajakta Varadkar
- Observations
- 2
- Pages
- 2
- FEI number
- 3003433722
In short: On December 5, 2023, FDA issued a Form 483 with 2 observations to Boehringer Ingelheim RCV GmbH & Co KG in Vienna, Austria (FEI 3003433722) after an inspection that ran Nov 29 – Dec 5, 2023. The investigator was Prajakta Varadkar. Most observations concern materials and facilities & equipment; the most-cited regulation is 21 CFR 211.150 (distribution procedures).
At a glance
Materials and facilities & equipment account for 2 of 2 observations.
Most cited: 21 CFR 211.150 (1×) · 211.67 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
SOP for critical steps…
- 02
Equipment preventive maintenance is not adequate…
This inspection in context
Prajakta Varadkar
3 documents · 2023–2025
Cites 211.100 (written procedures; deviations) more than any other section. Most of their documents are for sites in Austria.
The firmBoehringer Ingelheim RCV GmbH & Co KG history
All 2 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.150
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Boehringer Ingelheim RCV GmbH & Co KG?
FDA listed 2 observations on this Form 483, mostly about materials and facilities & equipment. The most-cited regulation is 21 CFR 211.150 (distribution procedures). The opening words of each observation are shown on this page.
Who inspected Boehringer Ingelheim RCV GmbH & Co KG?
Prajakta Varadkar is named on this Form 483, for the inspection of Nov 29 – Dec 5, 2023. Each investigator has a profile showing what they cite most.
When was Boehringer Ingelheim RCV GmbH & Co KG inspected by FDA?
The inspection ran Nov 29 – Dec 5, 2023, and the Form 483 is dated December 5, 2023.
How do I get the full Form 483 for Boehringer Ingelheim RCV GmbH & Co KG?
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.