FDA Inspection
Companion Medical, Inc.Companion Medical, Inc. – FDA Inspection, Aug 14, 2019
Record Details
This FDA Inspection record concerns Companion Medical, Inc., with an inspection on August 14, 2019, issued by the Center for Devices and Radiological Health, covering devices.
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ID · a8613883-af70-4485-b4d5-3ac070cce1d5
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 1101176
- FDA center
- Medical Devices & Rad Health
- Project area
- Compliance: Devices
- Outcome
- Form 483 issued
FDA Citations
3- 21 CFR 820.181DMR - not or inadequately maintained
- 21 CFR 820.100(a)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 Companion Medical, Inc.
1| Date | Classification | Office | Project area |
|---|---|---|---|
| August 4, 2023 | NAI | Center for Devices and Radiological Health | Postmarket Assurance: Devices |
Other documents for Companion Medical, Inc.
- FDA Inspection 1217408 - 2023-08-04
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