Merck & Cie KmG
Form 483 issued November 2, 2018 · Schaffhausen, Switzerland
- Inspection
- Oct 29 – Nov 2, 2018
- Investigator
- Tamil Arasu
- Observations
- 1
- Pages
- 1
- FEI number
- 3002806918
In short: On November 2, 2018, FDA issued a Form 483 with 1 observation to Merck & Cie KmG in Schaffhausen, Switzerland (FEI 3002806918) after an inspection that ran Oct 29 – Nov 2, 2018. The investigator was Tamil Arasu. Most observations concern facilities & equipment; the most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment).
At a glance
1 of 1 observations on this 483 concern facilities & equipment.
Most cited: 21 CFR 211.68 (1×)
What FDA observed
Preview: the opening words of each observationDashed: section inferred by FDA Intel and checked against the regulation text
- 01
Appropriate controls are not exercised over computers or related laboratory systems. A) User roles assigned to…
This inspection in context
Tamil Arasu
27 documents · 2011–2025
Cites 211.192 (production record review) more than any other section. Most of their documents are for sites in India.
The firmMerck & Cie KmG history
The site's inspection history, in date order.
Similar 483sOther sites cited under 211.68
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Merck & Cie KmG?
FDA listed 1 observation on this Form 483, mostly about facilities & equipment. The most-cited regulation is 21 CFR 211.68 (automatic, mechanical, and electronic equipment). The opening words of each observation are shown on this page.
Who inspected Merck & Cie KmG?
Tamil Arasu is named on this Form 483, for the inspection of Oct 29 – Nov 2, 2018. Each investigator has a profile showing what they cite most.
When was Merck & Cie KmG inspected by FDA?
The inspection ran Oct 29 – Nov 2, 2018, and the Form 483 is dated November 2, 2018.
How do I get the full Form 483 for Merck & Cie KmG?
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.