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FDA Inspection
•Imagine Milling Technologies, LLC•November 22, 2017

Imagine Milling Technologies, LLC – FDA Inspection, Nov 22, 2017

Record Details

This FDA Inspection record concerns Imagine Milling Technologies, LLC, with an inspection on November 22, 2017, issued by the Center for Devices and Radiological Health, covering devices.

Company
Imagine Milling Technologies, LLC
Inspection Date
November 22, 2017
Product Type
Devices
Office
Center for Devices and Radiological Health
Person
  • Wilfred A. Darang
View Company Profile

ID · e1103722-e232-432f-8ccf-ad31ba53bdef

Inspection Facts

No Action Indicated (NAI)

No objectionable conditions or practices were found during the inspection.

Inspection number
1031906
FDA center
Medical Devices & Rad Health
Project area
Postmarket Assurance: Devices
Outcome
Form 483 issued

FDA Citations

5
  1. 21 CFR 820.100(a)Lack of or inadequate procedures
  2. 21 CFR 820.198(a)Lack of or inadequate complaint procedures
  3. 21 CFR 820.20(c)Management review dates
  4. 21 CFR 820.22Quality Audit/Reaudit - conducted
  5. 21 CFR 820.30(a)Design control - no procedures

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Imagine Milling Technologies, LLC

2
DateClassificationOfficeProject area
February 1, 2023VAICenter for Devices and Radiological HealthCompliance: Devices
July 26, 2018NAICenter for Devices and Radiological HealthPostmarket Assurance: Devices
Other documents for Imagine Milling Technologies, LLC
  • FDA Inspection 1196099 - 2023-02-01
  • FDA Inspection 1060005 - 2018-07-26

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