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FDA Inspection
•Memorial Health University Medical Center•June 12, 2024

Memorial Health University Medical Center – FDA Inspection, Jun 12, 2024

Record Details

This FDA Inspection record concerns Memorial Health University Medical Center, with an inspection on June 12, 2024, issued by the Center for Biologics Evaluation and Research, covering biologics.

Company
Memorial Health University Medical Center
Inspection Date
June 12, 2024
Product Type
Biologics
Office
Center for Biologics Evaluation and Research
People
  • Danielle R. Rainey (Issuing Officer)
  • Kenneth L. Smalls (Issuing Officer)
View Company Profile

ID · a9e3c0da-0144-49e5-b174-d93eab5e2907

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
1241135
FDA center
Biologics
Project area
Blood and Blood Products

FDA Citations

2
  1. 21 CFR 606.140(b)Provisions to monitor lab test procedures & instruments
  2. 21 CFR 606.100(b)(15)Schedules and procedures for equipment & calibration

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Memorial Health University Medical Center

13
DateClassificationOfficeProject area
July 1, 2026NAICenter for Biologics Evaluation and ResearchBlood and Blood Products
September 1, 2022NAICenter for Biologics Evaluation and ResearchBlood and Blood Products
August 30, 2022VAICenter for Biologics Evaluation and ResearchBlood and Blood Products
February 6, 2018NAICenter for Biologics Evaluation and ResearchBlood and Blood Products
January 11, 2018NAICenter for Biologics Evaluation and ResearchBlood and Blood Products
View all 13 other inspections on the company page
Other documents for Memorial Health University Medical Center
  • FDA Inspection 1327260 - 2026-07-01
  • FDA Inspection 1181575 - 2022-09-01
  • FDA Inspection 1178940 - 2022-08-30
  • FDA Inspection 1048860 - 2018-02-06
  • FDA Inspection 1048863 - 2018-01-11

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