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FDA Inspection
•Pure Source LLC•July 28, 2026

Pure Source LLC – FDA Inspection, Jul 28, 2026

Record Details

This FDA Inspection record concerns Pure Source LLC, with an inspection on July 28, 2026, issued by the Florida District Office, covering medical devices & rad health.

Company
Pure Source LLC
Inspection Date
July 28, 2026
Product Type
Medical Devices & Rad Health
Office
Florida District Office
Person
  • Gisselle I. Sensebe (Issuing Officer)
View Company Profile

ID · 814cb657-e578-4276-a0b5-88558543863c

Inspection Facts

No Action Indicated (NAI)

No objectionable conditions or practices were found during the inspection.

Inspection number
1328392
FDA center
Medical Devices & Rad Health
Project area
Postmarket Assurance: Devices
Outcome
Form 483 issued, view the record

FDA Citations

1
  1. ISO 13485:2016 Clause 7.1Records of risk management activities in product realization not maintained

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Pure Source LLC

8
DateClassificationOfficeProject area
October 21, 2025Not classifiedFlorida District OfficeDrug Quality Assurance
August 31, 2023VAICenter for Devices and Radiological HealthCompliance: Devices
August 14, 2019VAICenter for Drug Evaluation and ResearchDrug Quality Assurance
March 1, 2018OAICenter for Veterinary MedicineMonitoring of Marketed Animal Drugs, Feed, and Devices
June 23, 2017VAICenter for Food Safety and Applied NutritionFood Composition, Standards, Labeling and Econ
View all 8 other inspections on the company page
Other documents for Pure Source LLC
  • FDA Inspection 1282596 - 2025-10-21
  • FDA Inspection 1216969 - 2023-08-31
  • FDA Inspection 1099548 - 2019-08-14
  • FDA Inspection 1042670 - 2018-03-01
  • FDA Inspection 1015800 - 2017-06-23

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