Sight Society Of Northeastern New York/Lions Eye Bank Of The Northeast FDA Inspection Record
Sight Society Of Northeastern New York/Lions Eye Bank Of The Northeast is an FDA-inspected facility (FEI 3000718056) located in Albany, NY, US. RegDataLab tracks 6 FDA inspections at this facility.
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What FDA found at this site
- Latest inspection
- Apr 30, 2025: No Action Indicated (NAI)
- Inspections on record
- 6 (2 VAI, 4 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
- Recalls as the recalling firm
- 5, latest Aug 21, 2017
Inspections and what FDA cited
| Date | Result | What FDA cited |
|---|---|---|
| Apr 30, 2025 | No Action Indicated (NAI) | No citations listed |
| Apr 4, 2018 | No Action Indicated (NAI) | No citations listed |
| Dec 22, 2015 | No Action Indicated (NAI) | No citations listed |
| Oct 15, 2013 | Voluntary Action Indicated (VAI) | Design of procedures to ensure compliance (21 CFR 1271.47(a)) Corrective actions (21 CFR 1271.260(d)) |
| Apr 5, 2012 | No Action Indicated (NAI) | No citations listed |
| Feb 22, 2010 | Voluntary Action Indicated (VAI) | Shipment in quarantine of HCT/Ps (21 CFR 1271.265(b)) Release criteria verified, documented (21 CFR 1271.265(c)(1)) Contract firms--identities and responsibilities (21 CFR 1271.270(e)) |
Recalls
| Date | Class | Recall | Product and reason |
|---|---|---|---|
| Aug 21, 2017 | Class II | B-0840-2017 | Cornea Human corneas, recovered from a donor whose donor eligibility determination failed to ensure that the donor was free from risk factors for… |
| May 25, 2015 | Class III | B-0821-15 | Cornea Human corneas, not tested adequately and appropriately to reduce the risk of transmission of relevant communicable diseases, were… |
| Jan 18, 2013 | Class II | B-2340-13 | Human Cornea for Transplant Preserved in Optisol GS --- Single Patient Use --- Lions Eye… Human Corneas, not tested to adequately and appropriately reduce the risk of transmission of relevant communicable disease agents or… |
| Apr 22, 2005 | Class II | B-1311-5 | Human Cornea for Transplant, Corneas Human tissue for transplantation, that tested negative for hepatitis prior to distribution, but was subsequently found to test repeatedly… |
| Aug 13, 2004 | Class II | B-2009-4 | Human Tissues for Transplantation, Corneas Human tissues for transplantation, that tested negative for viral markers, but was procured from an ineligible donor due to a high-risk… |
Facility details
- Company
- Sight Society Of Northeastern New York/Lions Eye Bank Of The Northeast
- Location
- Albany, NY (US)
- Source
- inspections