FDA Inspection
Euclide CareEuclide Care – FDA Inspection, May 24, 2018
Record Details
This FDA Inspection record concerns Euclide Care, with an inspection on May 24, 2018, issued by the Office of Inspections and Investigations, covering medical devices & rad health.
- Person
- Teresa K. Kastner
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ID · cee03e64-407b-4080-ad9d-223c16266136
Inspection Facts
- Inspection number
- 1053079
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
5- 21 CFR 803.17Lack of Written MDR Procedures
- 21 CFR 820.100(a)Lack of or inadequate procedures
- 21 CFR 820.184DHR - not or inadequately maintained
- 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures
- 21 CFR 820.90(b)(1)Procedures for product review,disposition lack of/inadequate
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Other FDA inspections of Euclide Care
1| Date | Classification | Office | Project area |
|---|---|---|---|
| May 21, 2025 | Not classified | Office of Inspections and Investigations | Compliance: Medical Devices |
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