Merck KGaA
Form 483 issued April 6, 2023 · Corsier-sur-Vevey, Switzerland
- Inspection
- Mar 30 – Apr 6, 2023
- Investigators
- Rakshit Patel· Santos E. Camara
- Observations
- 1
- Pages
- 2
- FEI number
- 3003131678
In short: On April 6, 2023, FDA issued a Form 483 with 1 observation to Merck KGaA in Corsier-sur-Vevey, Vaud (FEI 3003131678) after an inspection that ran Mar 30 – Apr 6, 2023. The investigators were Rakshit Patel and Santos E. Camara. Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance).
At a glance
1 of 1 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 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
Failure to adequately monitor the water purification system to ensure that water…
This inspection in context
Rakshit Patel
1 document · 2023
Cites 211.67 (equipment cleaning and maintenance) more than any other section. Most of their documents are for sites in Switzerland.
The firmMerck KGaA history
All 3 documents on file for this site, in date order, with what was cited at each inspection.
Similar 483sOther sites cited under 211.67
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Merck KGaA?
FDA listed 1 observation on this Form 483, mostly about facilities & equipment. The most-cited regulation is 21 CFR 211.67 (equipment cleaning and maintenance). The opening words of each observation are shown on this page.
Who inspected Merck KGaA?
Rakshit Patel and Santos E. Camara are named on this Form 483, for the inspection of Mar 30 – Apr 6, 2023. Each investigator has a profile showing what they cite most.
When was Merck KGaA inspected by FDA?
The inspection ran Mar 30 – Apr 6, 2023, and the Form 483 is dated April 6, 2023.
How do I get the full Form 483 for Merck KGaA?
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.