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FDA Inspection
•U.S. Navy Medicine Readiness and Training Command Rota Spain•May 14, 2019

U.S. Navy Medicine Readiness and Training Command Rota Spain – FDA Inspection, May 14, 2019

Record Details

This FDA Inspection record concerns U.S. Navy Medicine Readiness and Training Command Rota Spain, with an inspection on May 14, 2019, issued by the Center for Biologics Evaluation and Research, covering biologics.

Company
U.S. Navy Medicine Readiness and Training Command Rota Spain
Inspection Date
May 14, 2019
Product Type
Biologics
Office
Center for Biologics Evaluation and Research
Person
  • La-tasha M. Gunter (Issuing Officer)
View Company Profile

ID · 67c55a75-10fb-4c02-87f0-eed25d419711

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
1090197
FDA center
Biologics
Project area
Blood and Blood Products
Outcome
Form 483 issued

FDA Citations

2
  1. 21 CFR 606.160(a)(1)Concurrent documentation
  2. 21 CFR 606.100(c)Record review prior to release

Full citation text and observation details available on the Dashboard.

Other FDA inspections of U.S. Navy Medicine Readiness and Training Command Rota Spain

7
DateClassificationOfficeProject area
August 7, 2025Not classifiedOffice of Inspections and Investigations
July 25, 2023NAICenter for Biologics Evaluation and ResearchBlood and Blood Products
May 17, 2017VAICenter for Biologics Evaluation and ResearchBlood and Blood Products
June 1, 2015NAICenter for Biologics Evaluation and ResearchBlood and Blood Products
June 18, 2013NAICenter 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 Rota Spain
  • FDA Inspection 1279065 - 2025-08-07
  • FDA Inspection 1215474 - 2023-07-25
  • FDA Inspection 1016453 - 2017-05-17
  • FDA Inspection 930574 - 2015-06-01
  • FDA Inspection 836851 - 2013-06-18

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