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FDA Inspection
•Mission Hospital Regional Medical Center•February 4, 2019

Mission Hospital Regional Medical Center – FDA Inspection, Feb 4, 2019

Record Details

This FDA Inspection record concerns Mission Hospital Regional Medical Center, with an inspection on February 4, 2019, issued by the Center for Biologics Evaluation and Research, covering biologics.

Company
Mission Hospital Regional Medical Center
Inspection Date
February 4, 2019
Product Type
Biologics
Office
Center for Biologics Evaluation and Research
Person
  • Kathleen B. Swat (FDA Associated Person)
View Company Profile

ID · a1468944-f208-4b0e-9984-3e10efe46d90

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
1078101
FDA center
Biologics
Project area
Blood and Blood Products
Outcome
Form 483 issued

FDA Citations

1
  1. 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 Mission Hospital Regional Medical Center

6
DateClassificationOfficeProject area
August 15, 2024NAICenter for Biologics Evaluation and ResearchBlood and Blood Products
March 13, 2017NAICenter for Biologics Evaluation and ResearchBlood and Blood Products
November 24, 2015NAICenter for Biologics Evaluation and ResearchBlood and Blood Products
January 23, 2014NAICenter for Biologics Evaluation and ResearchBlood and Blood Products
April 17, 2012VAICenter for Biologics Evaluation and ResearchBlood and Blood Products
View all 6 other inspections on the company page
Other documents for Mission Hospital Regional Medical Center
  • FDA Inspection 1249306 - 2024-08-15
  • FDA Inspection 1009001 - 2017-03-13
  • FDA Inspection 950100 - 2015-11-24
  • FDA Inspection 867128 - 2014-01-23
  • FDA Inspection 777258 - 2012-04-17

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