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FDA Inspection
•Richmond VA Medical Center•May 12, 2026

Richmond VA Medical Center – FDA Inspection, May 12, 2026

Record Details

This FDA Inspection record concerns Richmond VA Medical Center, with an inspection on May 12, 2026, issued by the Baltimore District Office, covering human drugs.

Company
Richmond VA Medical Center
Inspection Date
May 12, 2026
Product Type
Human Drugs
Office
Baltimore District Office
People
  • Michael O. Idowu (Company Rep)
  • Tekalign Wondimu (FDA Associated Person)
View Company Profile

ID · e0de3476-7205-4db2-b13f-8e1c6a197531

Inspection Facts

Inspection number
1316794
FDA center
Human Drugs
Project area
Drug Quality Assurance
Outcome
Form 483 issued

FDA Citations

8
  1. FDCA 501(a)(2)(A)Failure to clean and disinfect/sterilize equipment, ISO 5 area
  2. FDCA 501(a)(2)(A)Inadequate smoke studies
  3. FDCA 501(a)(2)(A)Insufficient use, disinfectant
  4. FDCA 501(a)(2)(A)Lack of disinfection, equipment/supplies from lower to higher quality air
  5. FDCA 501(a)(2)(A)Personnel, blocked or disrupted first air
  6. FDCA 501(a)(2)(A)Personnel exposure during aseptic manipulations
  7. FDCA 501(a)(2)(A)Personnel moving quickly, disrupting unidirectional airflow
  8. FDCA 501(a)(2)(A)Sporicidal agent, ISO 5/classified areas

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Richmond VA Medical Center

11
DateClassificationOfficeProject area
November 30, 2023NAICenter for Biologics Evaluation and ResearchBlood and Blood Products
April 21, 2022NAICenter for Biologics Evaluation and ResearchVaccines and Allergenic Products
January 25, 2019NAICenter for Biologics Evaluation and ResearchBlood and Blood Products
July 19, 2018VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
April 11, 2017NAICenter for Biologics Evaluation and ResearchBlood and Blood Products
View all 11 other inspections on the company page
Other documents for Richmond VA Medical Center
  • FDA Inspection 1225014 - 2023-11-30
  • FDA Inspection 1168190 - 2022-04-21
  • FDA Inspection 1078446 - 2019-01-25
  • FDA Inspection 1060421 - 2018-07-19
  • FDA Inspection 1012428 - 2017-04-11

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