Boehringer Ingelheim RCV GmbH & Co KG
Form 483 issued November 23, 2018 · Vienna, Austria
- Inspection
- Nov 19 – Nov 23, 2018
- Investigators
- Maria Jose Lopez Barragan· Ram Sihag· Richard Ledwidge
- Observations
- 1
- Pages
- 1
- FEI number
- 3003433722
In short: On November 23, 2018, FDA issued a Form 483 with 1 observation to Boehringer Ingelheim RCV GmbH & Co KG in Vienna, Austria (FEI 3003433722) after an inspection that ran Nov 19 – Nov 23, 2018. The investigators were Maria Jose Lopez Barragan, Ram Sihag and Richard Ledwidge.
What FDA observed
Preview: the opening words of each observation- 01
process equipment is inadequate to assure that equipment surfaces do not alter the…
This inspection in context
Maria Jose Lopez Barragan
2 documents · 2017–2018
Cites 211.111 (time limitations on production) 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.
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Questions about this 483
What did FDA find at Boehringer Ingelheim RCV GmbH & Co KG?
FDA listed 1 observation on this Form 483. The opening words of each observation are shown on this page.
Who inspected Boehringer Ingelheim RCV GmbH & Co KG?
Maria Jose Lopez Barragan, Ram Sihag and Richard Ledwidge are named on this Form 483, for the inspection of Nov 19 – Nov 23, 2018. 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 19 – Nov 23, 2018, and the Form 483 is dated November 23, 2018.
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.