ABAXIS, INC. FDA Inspection Record
ABAXIS, INC. is an FDA-registered facility (FEI 2939693) located in UNION CITY, CA, US. RegDataLab tracks 5 FDA inspections and 1 compliance action at this facility.
What FDA found at this site
- Latest inspection
- Aug 22, 2019: Voluntary Action Indicated (VAI)
- Inspections on record
- 5 (1 OAI, 2 VAI, 2 NAI)
- Last OAI inspection
- Apr 25, 2018
- Warning letters
- 1 listed by FDA for this FEI, latest Apr 12, 2019
- Recalls as the recalling firm
- 1, latest Dec 11, 2019
- Import refusals
- 5
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Aug 22, 2019 | Voluntary Action Indicated (VAI) | Evaluation, timeliness, identification (21 CFR 820.198(d)) Management review - defined interval, sufficient frequency (21 CFR 820.20(c)) Report of Death or Serious Injury (21 CFR 803.50(a)(1)) |
| Apr 25, 2018 | Official Action Indicated (OAI) | Design changes - Lack of or Inadequate Procedures (21 CFR 820.30(i)) Design Validation - Risk analysis not performed/inadequate (21 CFR 820.30(g)) Production and Process Change Procedures, lack of or Inad. (21 CFR 820.70(b)) |
| Sep 10, 2014 | No Action Indicated (NAI) | No citations listed |
| Apr 3, 2012 | No Action Indicated (NAI) | No citations listed |
| Dec 22, 2010 | Voluntary Action Indicated (VAI) | Availability (21 CFR 820.180) |
Warning letters
- Apr 12, 2019. Read the letter on FDA.gov.
Recalls
| Date | Class | Recall | Product and reason |
|---|---|---|---|
| Dec 11, 2019 | Class II | Z-2361-2020 | Piccolo Xpress chemistry analyzer, Model No. 1100-1001, Software version 2.1.55… Incorrect reference ranges of analytes. |
FDA record score
18 of 100. A count of this site's adverse public FDA records, weighted by how recent each one is. A higher number means more, or more recent, records. Each record below adds the points shown.
5 records behind this number
| Record | Date | Points x age weight | Adds |
|---|---|---|---|
| Warning letter, no close-out letter listed | Apr 12, 2019 | 30 x 0.25 | 7.5 |
| Inspection classified OAI | Apr 25, 2018 | 30 x 0.25 | 7.5 |
| Inspection classified VAI | Aug 22, 2019 | 6 x 0.25 | 1.5 |
| Class II recall Z-2361-2020, this FEI as the recalling firm | Dec 11, 2019 | 4 x 0.25 | 1 |
| Inspection classified VAI | Dec 22, 2010 | 10 years or older, so it adds no points | 0 |
When each source was last refreshed
| Records | Last refreshed | Source as of | Status |
|---|---|---|---|
| Inspections | Nov 15, 2026 | Newest record Nov 5, 2026 | Current |
| Inspection citations | Nov 15, 2026 | Newest record Nov 5, 2026 | Current |
| Compliance actions (warning letters, injunctions and other action types) | Nov 2, 2026 | Newest record Oct 29, 2026 | Current |
| Warning letter text | Nov 14, 2026 | Newest record Nov 10, 2026 | Current |
| Recalls (Enforcement Report) | Nov 15, 2026 | Newest record Nov 11, 2026 | Current |
| Form 483s and inspection documents | Nov 13, 2026 | Newest record Nov 12, 2026 | Current |
| Import refusals | Nov 15, 2026 | Newest record Nov 5, 2026 | Current |
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Facility details
- Company
- Abaxis Inc
- Location
- UNION CITY, CA (US)
- Source
- device