Aroa Biosurgery Ltd — FDA Facility Profile
Aroa Biosurgery Ltd is an FDA-registered facility (FEI 3007321028) located in Airport Oaks Auckland, NZ. RegDataLab tracks 1 FDA inspection at this facility.
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What FDA found at this site
- Latest inspection
- Mar 9, 2017: 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 Apr 6, 2018
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Mar 9, 2017 | Voluntary Action Indicated (VAI) | No citations listed |
Recalls
| Date | Class | Recall | Product and reason |
|---|---|---|---|
| Apr 6, 2018 | Class II | Z-0415-2019 | OviTex Reinforced BioScaffold 4x8cm, Part Number F10254-0408G and 20 more products Degradation of the PGA suture material used in the manufacture of the resorbable mesh devices was observed during an on-going product… |
Facility details
- Company
- Aroa Biosurgery Ltd
- Location
- Airport Oaks Auckland (NZ)
- Source
- device