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FDA Inspection
•Bahadir USA LLC•July 17, 2023

Bahadir USA LLC – FDA Inspection, Jul 17, 2023

Record Details

This FDA Inspection record concerns Bahadir USA LLC, with an inspection on July 17, 2023, issued by the Center for Devices and Radiological Health, covering devices.

Company
Bahadir USA LLC
Inspection Date
July 17, 2023
Product Type
Devices
Office
Center for Devices and Radiological Health
Person
  • Shirley S. Wen (Issuing Officer)
View Company Profile

ID · 5db4cd98-521e-48a2-9d23-825fda247219

Inspection Facts

No Action Indicated (NAI)

No objectionable conditions or practices were found during the inspection.

Inspection number
1210183
FDA center
Medical Devices & Rad Health
Project area
Compliance: Devices
Outcome
Form 483 issued

FDA Citations

2
  1. 21 CFR 820.184Lack of or inadequate DHR procedures
  2. 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Bahadir USA LLC

2
DateClassificationOfficeProject area
September 21, 2016NAICenter for Devices and Radiological HealthPostmarket Assurance: Devices
October 28, 2013NAICenter for Devices and Radiological HealthCompliance: Devices
Other documents for Bahadir USA LLC
  • FDA Inspection 985509 - 2016-09-21
  • FDA Inspection 853380 - 2013-10-28

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