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FDA Inspection
•Advancing Sight Network•March 4, 2016

Advancing Sight Network – FDA Inspection, Mar 4, 2016

Record Details

This FDA Inspection record concerns Advancing Sight Network, with an inspection on March 4, 2016, issued by the Center for Biologics Evaluation and Research, covering biologics.

Company
Advancing Sight Network
Inspection Date
March 4, 2016
Product Type
Biologics
Office
Center for Biologics Evaluation and Research
View Company Profile

ID · b4e2f09c-d864-4c23-89ba-a62241783e51

Inspection Facts

Voluntary Action Indicated (VAI)

Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.

Inspection number
965674
FDA center
Biologics
Project area
Human Cellular, Tissue, and Gene Therapies

FDA Citations

5
  1. 21 CFR 1271.195(a)Adequate control, proper conditions
  2. 21 CFR 1271.180(a)Procedures to meet core CTGP
  3. 21 CFR 1271.47(a)Testing, screening, donor eligibility procedures
  4. 21 CFR 1271.270(a)Records maintained concurrently
  5. 21 CFR 1271.230(a)Documented, dated, signed

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Advancing Sight Network

4
DateClassificationOfficeProject area
May 26, 2022NAICenter for Biologics Evaluation and ResearchHuman Cellular, Tissue, and Gene Therapies
June 12, 2018NAICenter for Biologics Evaluation and ResearchHuman Cellular, Tissue, and Gene Therapies
April 2, 2013NAICenter for Biologics Evaluation and ResearchHuman Cellular, Tissue, and Gene Therapies
December 10, 2009NAICenter for Biologics Evaluation and ResearchHuman Cellular, Tissue, and Gene Therapies
Other documents for Advancing Sight Network
  • FDA Inspection 1170771 - 2022-05-26
  • FDA Inspection 1056874 - 2018-06-12
  • FDA Inspection 825529 - 2013-04-02
  • FDA Inspection 634006 - 2009-12-10

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