FDA Inspection 648106 — Sight Society Of Northeastern New York/Lions Eye Bank of the Northeast

Sight Society Of Northeastern New York/Lions Eye Bank of the Northeast — FEI 3000718056

The FDA completed an inspection of Sight Society Of Northeastern New York/Lions Eye Bank of the Northeast on February 22, 2010 in Albany, NY. The inspection was classified VAI (Voluntary Action Indicated — objectionable conditions were found but do not meet the threshold for regulatory action). 3 citations were issued during this inspection. Product area: Biologics.

Inspection Details

Classification
Voluntary Action Indicated (VAI) (VAI)
End Date
February 22, 2010
Fiscal Year
2010
Product Type
Biologics
Project Area
Human Cellular, Tissue, and Gene Therapies
Location
Albany, NY (United States)

Citations

IDCFRDescription
1242321 CFR 1271.265(b)Shipment in quarantine of HCT/Ps
1242421 CFR 1271.265(c)(1)Release criteria verified, documented
1244421 CFR 1271.270(e)Contract firms--identities and responsibilities