Companion Medical, Inc. — FDA Facility Profile
Companion Medical, Inc. is an FDA-inspected facility (FEI 3012822846) located in San Diego, CA, US. RegDataLab tracks 2 FDA inspections at this facility.
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What FDA found at this site
- Latest inspection
- Aug 4, 2023: No Action Indicated (NAI)
- Inspections on record
- 2 (1 VAI, 1 NAI)
- Last OAI inspection
- None on record
- Warning letters
- None matched to this FEI. Many letters do not state an FEI: search warning letters by company name
- Recalls as the recalling firm
- 1, latest Nov 8, 2022
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Aug 4, 2023 | No Action Indicated (NAI) | No citations listed |
| Aug 14, 2019 | Voluntary Action Indicated (VAI) | Lack of or inadequate procedures (21 CFR 820.100(a)) Procedures for product review,disposition lack of/inadequate (21 CFR 820.90(b)(1)) DMR - not or inadequately maintained (21 CFR 820.181) |
Recalls
| Date | Class | Recall | Product and reason |
|---|---|---|---|
| Nov 8, 2022 | Not yet classified | Z-0741-2023 | InPen Diabetes Management App, part of the InPen System, REF: MMT-105ELBLNA… Diabetes management app may crash immediately upon opening, while using the app and/or while app is running in the background, which may… |
Facility details
- Company
- Companion Medical, Inc.
- Location
- San Diego, CA (US)
- Source
- inspections