CAIRE DIAGNOSTICS INC — FDA Facility Profile
CAIRE DIAGNOSTICS INC is an FDA-inspected facility (FEI 3013216353) located in Pleasanton, CA, US. RegDataLab tracks 1 FDA inspection at this facility.
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What FDA found at this site
- Latest inspection
- Aug 3, 2021: Voluntary Action Indicated (VAI)
- Inspections on record
- 1 (1 VAI)
- 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 Feb 26, 2021
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Aug 3, 2021 | Voluntary Action Indicated (VAI) | DHR - not or inadequately maintained (21 CFR 820.184) Lack of or inadequate procedures (21 CFR 820.100(a)) Investigation of device failures (21 CFR 820.198(c)) Identification procedures, Lack of or inadequate procedures (21 CFR 820.60) |
Recalls
| Date | Class | Recall | Product and reason |
|---|---|---|---|
| Feb 26, 2021 | Not yet classified | Z-1284-2021 | CAIRE DIAGNOSTICS FenomPro REF 900-0001 SN ***** - Product Usage: a portable, non-invasive… Erroneously high FeNO levels which may contribute to premature discontinuation of effective asthma treatment and persistent underlying… |
Facility details
- Company
- CAIRE DIAGNOSTICS INC
- Location
- Pleasanton, CA (US)
- Source
- inspections