FDA Inspection
ELCAT GmbHELCAT GmbH – FDA Inspection, Jan 31, 2019
Record Details
This FDA Inspection record concerns ELCAT GmbH, with an inspection on January 31, 2019, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
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ID · e6dec671-943f-4d76-be9c-df79fe01f6c7
Inspection Facts
- Inspection number
- 1077644
- FDA center
- Medical Devices & Rad Health
- Project area
- Postmarket Assurance: Devices
- Outcome
- Form 483 issued
FDA Citations
2- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.30(i)Design changes - Lack of or Inadequate Procedures
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