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FDA Inspection
•U.S. Navy Medicine Readiness and Training Command Sigonella Italy•June 4, 2013

U.S. Navy Medicine Readiness and Training Command Sigonella Italy – FDA Inspection, Jun 4, 2013

Record Details

This FDA Inspection record concerns U.S. Navy Medicine Readiness and Training Command Sigonella Italy, with an inspection on June 4, 2013, issued by the Center for Biologics Evaluation and Research, covering biologics.

Company
U.S. Navy Medicine Readiness and Training Command Sigonella Italy
Inspection Date
June 4, 2013
Product Type
Biologics
Office
Center for Biologics Evaluation and Research
View Company Profile

ID · ab6de402-0110-4a6f-af67-86106fc5ba03

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
836841
FDA center
Biologics
Project area
Blood and Blood Products

FDA Citations

3
  1. 21 CFR 606.60(a)Maintain and clean equipment
  2. 21 CFR 606.100(c)Thorough investigations
  3. 21 CFR 606.100(b)Establish, maintain and follow manufacturing SOPs

Full citation text and observation details available on the Dashboard.

Other FDA inspections of U.S. Navy Medicine Readiness and Training Command Sigonella Italy

7
DateClassificationOfficeProject area
April 18, 2025NAICenter for Biologics Evaluation and ResearchBlood and Blood Products
July 18, 2023NAICenter for Biologics Evaluation and ResearchBlood and Blood Products
May 3, 2019NAICenter for Biologics Evaluation and ResearchBlood and Blood Products
May 10, 2017VAICenter for Biologics Evaluation and ResearchBlood and Blood Products
June 11, 2015NAICenter for Biologics Evaluation and ResearchBlood and Blood Products
View all 7 other inspections on the company page
Other documents for U.S. Navy Medicine Readiness and Training Command Sigonella Italy
  • FDA Inspection 1271184 - 2025-04-18
  • FDA Inspection 1215246 - 2023-07-18
  • FDA Inspection 1092612 - 2019-05-03
  • FDA Inspection 1015126 - 2017-05-10
  • FDA Inspection 931824 - 2015-06-11

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