BOX MEDICAL SOLUTIONS, INC — FDA Facility Profile
BOX MEDICAL SOLUTIONS, INC is an FDA-registered facility (FEI 3012966929) located in Thousand Oaks, CA, US. RegDataLab tracks 3 FDA inspections at this facility.
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What FDA found at this site
- Latest inspection
- Feb 15, 2023: No Action Indicated (NAI)
- Inspections on record
- 3 (2 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
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Feb 15, 2023 | No Action Indicated (NAI) | No citations listed |
| Jan 30, 2020 | Voluntary Action Indicated (VAI) | Design control - no procedures (21 CFR 820.30(a)) Lack of or inadequate final acceptance procedures (21 CFR 820.80(d)) Design validation - software validation not performed (21 CFR 820.30(g)) |
| Nov 1, 2018 | Voluntary Action Indicated (VAI) | Lack of or inadequate complaint procedures (21 CFR 820.198(a)) Quality policy and objectives (21 CFR 820.20(a)) Quality audits - Lack of or inadequate procedures (21 CFR 820.22) Training - Lack of or inadequate procedures (21 CFR 820.25(b)) and 5 more |
Facility details
- Company
- BOX MEDICAL SOLUTIONS INC.
- Location
- Thousand Oaks, CA (US)
- Source
- device