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FDA Inspection
•RNA Bio/Pharma Inc•April 11, 2025

RNA Bio/Pharma Inc – FDA Inspection, Apr 11, 2025

Record Details

This FDA Inspection record concerns RNA Bio/Pharma Inc, with an inspection on April 11, 2025, issued by the Seattle District Office, covering human drugs.

Company
RNA Bio/Pharma Inc
Inspection Date
April 11, 2025
Product Type
Human Drugs
Office
Seattle District Office
Person
  • Bryan L. Mcguckin
View Company Profile

ID · c7c1c61f-a078-481e-a9be-bf3a44e4cb45

Inspection Facts

Official Action Indicated (OAI)

Significant objectionable conditions were found and regulatory or administrative action is recommended.

Inspection number
1266530
FDA center
Human Drugs
Project area
Drug Quality Assurance
Outcome
Form 483 issued, view the record

FDA Citations

4
  1. 21 CFR 211.110(a)Control procedures to monitor and validate performance
  2. 21 CFR 211.84(d)(2)Component identification test
  3. 21 CFR 211.22(a)Lack of quality control unit
  4. 21 CFR 211.166(c)(1)Homeopathic drugs, assessment of stability

Full citation text and observation details available on the Dashboard.

Other FDA inspections of RNA Bio/Pharma Inc

4
DateClassificationOfficeProject area
June 25, 2019NAICenter for Drug Evaluation and ResearchDrug Quality Assurance
September 20, 2017NAICenter for Food Safety and Applied NutritionFoodborne Biological Hazards
May 24, 2013VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
October 31, 2008VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
Other documents for RNA Bio/Pharma Inc
  • FDA Inspection 1097487 - 2019-06-25
  • FDA Inspection 1030091 - 2017-09-20
  • FDA Inspection 834118 - 2013-05-24
  • FDA Inspection 546350 - 2008-10-31

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