FDA Intel

Merck KGaA

FDA inspection history across 2 sites, 2011 to 2023

1
Form 483
1
Close-out
1
Warning letter

Every document, by year

  • Form 483
  • Close-out
  • Warning letter

2011: one warning letter; 2014: one close-out letter; 2023: one Form 483.

The story so far

Built from the dates and citations on the documents themselves.

  1. 2011One warning letter, at Darmstadt, Germany.
  2. 2014One close-out letter, at Darmstadt, Germany.
  3. 2023One Form 483, at Corsier-sur-Vevey, Switzerland.

Cited most

Across all Merck KGaA observations on file

The complete Merck KGaA file.

All 3 documents as original PDFs, in one order. For supplier audits, diligence and inspection prep.

$297

The price of the documents, added to your cart together

Sites

Documents

3 on file, newest first
DateDocumentPrice
2023-04-06483 Form 483$99
2014-03-18Close-out Close-out letter$99
2011-12-15Warning letter Warning letter$99

Investigators on these documents

Rakshit Patel (1)Santos E. Camara (1)

FEI number 3003131678 · most recent document Apr 6, 2023

About Merck KGaA

How many FDA Form 483s has Merck KGaA received?

FDA Intel has 1 Form 483 on file for Merck KGaA; the most recent is dated Apr 6, 2023.

When was Merck KGaA last inspected by FDA?

The most recent FDA inspection document on file for Merck KGaA is a Form 483 dated Apr 6, 2023, for the site in Corsier-sur-Vevey, Switzerland.

What did FDA cite at Merck KGaA?

The regulations cited most in the observations on file for Merck KGaA are 21 CFR 211.67 (Equipment cleaning and maintenance), 1 time.

Has Merck KGaA received an FDA warning letter?

Yes. FDA Intel has 1 FDA warning letter on file for Merck KGaA; the most recent is dated Dec 15, 2011.