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FDA Inspection
•Modern Surgical Inc•October 22, 2009

Modern Surgical Inc – FDA Inspection, Oct 22, 2009

Record Details

This FDA Inspection record concerns Modern Surgical Inc, with an inspection on October 22, 2009, issued by the Center for Biologics Evaluation and Research, covering biologics.

Company
Modern Surgical Inc
Inspection Date
October 22, 2009
Product Type
Biologics
Office
Center for Biologics Evaluation and Research
View Company Profile

ID · a6847308-fe11-45c4-a6ce-c4ae7cd580a5

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
622889
FDA center
Biologics
Project area
Human Cellular, Tissue, and Gene Therapies

FDA Citations

2
  1. 21 CFR 1271.260(e)Storage temperatures recorded, maintained
  2. 21 CFR 803.17Lack of Written MDR Procedures

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Modern Surgical Inc

2
DateClassificationOfficeProject area
March 19, 2012NAICenter for Biologics Evaluation and ResearchHuman Cellular, Tissue, and Gene Therapies
December 11, 2008OAICenter for Biologics Evaluation and ResearchHuman Cellular, Tissue, and Gene Therapies
Other documents for Modern Surgical Inc
  • FDA Inspection 773352 - 2012-03-19
  • FDA Inspection 551933 - 2008-12-11

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