Company
GermanyMerck KGaA, Darmstadt, Germany – FDA Inspections
Inspection records and compliance data for Merck KGaA in Darmstadt. 6 FDA inspections on record, last inspected July 19, 2024.
Company Profile
This profile covers Merck KGaA based in Darmstadt, Germany.
FDA Inspection History
- FDA inspections
- 6
- OAI
- 0
- VAI
- 2
- NAI
- 4
- Form 483s
- 0
- Warning letters
- 0
First inspected July 2, 2009. Last inspected July 19, 2024.
Most cited issue areas
- Legibility1 inspection
- Nonconforming product, Lack of or inadequate procedures1 inspection
- Training records1 inspection
FDA inspections (6)
| Date | Result | FDA center(s) | Insp. # |
|---|---|---|---|
| July 19, 2024 | NAI | Biologics · Blood and Blood Products | 1233993 |
| October 6, 2023 | VAI | Human Drugs · Drug Quality Assurance | 1241023 |
| September 8, 2017 | NAI | Animal Drugs & Feeds, Human Drugs · Drug Quality Assurance | 1029948 |
| February 27, 2014 | NAI | Human Drugs · Drug Quality Assurance | 867759 |
| February 10, 2010 | NAI | Human Drugs · Drug Quality Assurance | 653955 |
| July 2, 2009 | VAI | Medical Devices & Rad Health · Compliance: Devices | 599121 |
FDA documents
Form 483s (1)
EIRs (1)
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Company Information
Name
Merck KGaA
FEI Number
3002806906
Address
Frankfurter Str. 250, Darmstadt, Germany
Country
Germany
ID: b5abb295-f221-4b66-9a49-d564f70c388b