FDA Inspection
Lions Eye Bank Of District 2t-1 Northwest Texas HospitalLions Eye Bank Of District 2t-1 Northwest Texas Hospital – FDA Inspection, Nov 18, 2009
Record Details
This FDA Inspection record concerns Lions Eye Bank Of District 2t-1 Northwest Texas Hospital, with an inspection on November 18, 2009, issued by the Center for Biologics Evaluation and Research, covering biologics.
- Inspection Date
- November 18, 2009
- Product Type
- Biologics
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ID · 6d190e47-b7ee-45cc-87c4-82e88e0197e4
Inspection Facts
Voluntary Action Indicated (VAI)
Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.
- Inspection number
- 629661
- FDA center
- Biologics
- Project area
- Human Cellular, Tissue, and Gene Therapies
FDA Citations
3- 21 CFR 1271.350(a)(2)15 day reporting timeframe
- 21 CFR 1271.180(a)Procedures to meet core CTGP
- 21 CFR 1271.260(a)Contamination, mix ups, improper release
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