HYPHEN BIOMED SASU FDA Inspection Record
HYPHEN BIOMED SASU is an FDA-registered facility (FEI 3004434070) located in NEUVILLE SUR OISE Val-d'Oise, FR. RegDataLab tracks 2 FDA inspections and 1 compliance action at this facility.
What FDA found at this site
- Latest inspection
- Feb 13, 2014: Official Action Indicated (OAI)
- Inspections on record
- 2 (2 OAI)
- Last OAI inspection
- Feb 13, 2014
- Warning letters
- 1 listed by FDA for this FEI, latest Sep 5, 2012
- Recalls as the recalling firm
- 2, latest Feb 5, 2018
- Import refusals
- 3
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Feb 13, 2014 | Official Action Indicated (OAI) | No citations listed |
| Jun 20, 2012 | Official Action Indicated (OAI) | Procedures not adequately established or maintained (21 CFR 820.40) Quality audits - Lack of or inadequate procedures (21 CFR 820.22) DHR content (21 CFR 820.184) Calibration, Inspection, etc. Procedures Lack of or Inadequ (21 CFR 820.72(a)) and 1 more |
Recalls
| Date | Class | Recall | Product and reason |
|---|---|---|---|
| Feb 5, 2018 | Class II | Z-1742-2018 | ZYMUTEST HIA MonoStrip IgG; REF Number: RK041A; UDI: 03663537046803 a qualitative assay… and 2 more products Incorrect package insert indicating use of the kits with plasma, serum, and other biological fluids. The kits should only be used with… |
| Nov 9, 2011 | Class II | Z-1062-2018 | ZYMUTEST HIA IgGAM.
Model Number: RK040D.
Qualitative screening assay for the detection… and 1 more product A voluntary recall is initiated for ZYMUTEST HIA lgGAM - Ref RK040D - Lot F1700415 and ZYMUTEST HIA MonoStrip lgGAM - Ref RK041D - Lot… |
FDA record score
1 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 |
|---|---|---|---|
| Class II recall Z-1742-2018, this FEI as the recalling firm | Feb 5, 2018 | 4 x 0.25 | 1 |
| Inspection classified OAI | Feb 13, 2014 | 10 years or older, so it adds no points | 0 |
| Warning letter on FDA's dashboard, which does not show close-outs | Sep 5, 2012 | 10 years or older, so it adds no points | 0 |
| Inspection classified OAI | Jun 20, 2012 | 10 years or older, so it adds no points | 0 |
| Class II recall Z-1062-2018, this FEI as the recalling firm | Nov 9, 2011 | 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 14, 2026 | Newest record Nov 5, 2026 | Current |
| Inspection citations | Nov 14, 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 14, 2026 | Newest record Nov 11, 2026 | Current |
| Form 483s and inspection documents | Nov 13, 2026 | Newest record Nov 12, 2026 | Current |
| Import refusals | Nov 2, 2026 | Newest record Oct 22, 2026 | Current |
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Facility details
- Company
- Hyphen BioMed Sasu
- Location
- NEUVILLE SUR OISE Val-d'Oise (FR)
- Source
- device