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FDA Inspection
•Advanced Surgicare, LLC•March 6, 2015

Advanced Surgicare, LLC – FDA Inspection, Mar 6, 2015

Record Details

This FDA Inspection record concerns Advanced Surgicare, LLC, with an inspection on March 6, 2015, issued by the Center for Biologics Evaluation and Research, covering biologics.

Company
Advanced Surgicare, LLC
Inspection Date
March 6, 2015
Product Type
Biologics
Office
Center for Biologics Evaluation and Research
View Company Profile

ID · 7ee1e3b2-b1ea-4308-88bd-c73255c38be6

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
917949
FDA center
Biologics
Project area
Human Cellular, Tissue, and Gene Therapies

FDA Citations

1
  1. 21 CFR 1271.160(a)All core requirements covered in program

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Advanced Surgicare, LLC

2
DateClassificationOfficeProject area
December 6, 2012VAICenter for Biologics Evaluation and ResearchHuman Cellular, Tissue, and Gene Therapies
September 10, 2010VAICenter for Biologics Evaluation and ResearchHuman Cellular, Tissue, and Gene Therapies
Other documents for Advanced Surgicare, LLC
  • FDA Inspection 809585 - 2012-12-06
  • FDA Inspection 679660 - 2010-09-10

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