FDA Inspection
Merck KGaAMerck KGaA – FDA Inspection, Jul 2, 2009
Record Details
This FDA Inspection record concerns Merck KGaA, with an inspection on July 2, 2009, issued by the Center for Devices and Radiological Health, covering devices.
- Company
- Merck KGaA
- Inspection Date
- July 2, 2009
- Product Type
- Devices
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ID · c5f114c3-c9d9-4b0e-85ca-a9c600a6078e
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 599121
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
FDA Citations
3- 21 CFR 820.25(b)Training records
- 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
- 21 CFR 820.180Legibility
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Other FDA inspections of Merck KGaA
5| Date | Classification | Office | Project area |
|---|---|---|---|
| July 19, 2024 | NAI | Center for Biologics Evaluation and Research | Blood and Blood Products |
| October 6, 2023 | VAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| September 8, 2017 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 27, 2014 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
| February 10, 2010 | NAI | Center for Drug Evaluation and Research | Drug Quality Assurance |
Other documents for Merck KGaA
- FDA Inspection 1233993 - 2024-07-19
- FDA Inspection 1241023 - 2023-10-06
- FDA Inspection 1029948 - 2017-09-08
- FDA Inspection 867759 - 2014-02-27
- FDA Inspection 653955 - 2010-02-10
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