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FDA Inspection
•D. O. Weaver and Company•May 12, 2023

D. O. Weaver and Company – FDA Inspection, May 12, 2023

Record Details

This FDA Inspection record concerns D. O. Weaver and Company, with an inspection on May 12, 2023, issued by the Center for Devices and Radiological Health, covering devices.

Company
D. O. Weaver and Company
Inspection Date
May 12, 2023
Product Type
Devices
Office
Center for Devices and Radiological Health
Person
  • Matthew M. Vernon (Company Rep)
View Company Profile

ID · f63ae782-4c99-470f-a51f-46c05d5f7a2d

Inspection Facts

Voluntary Action Indicated (VAI)

Objectionable conditions were found, but FDA is not prepared to take or recommend regulatory action.

Inspection number
1205081
FDA center
Medical Devices & Rad Health
Project area
Compliance: Devices
Outcome
Form 483 issued

FDA Citations

4
  1. 21 CFR 820.75(a)Lack of or inadequate process validation
  2. 21 CFR 820.198(d)Records of MDR Investigation
  3. 21 CFR 820.198(d)Records of MDR Investigation
  4. 21 CFR 820.75(a)Lack of or inadequate process validation

Full citation text and observation details available on the Dashboard.

Other FDA inspections of D. O. Weaver and Company

2
DateClassificationOfficeProject area
November 10, 2016VAICenter for Devices and Radiological HealthCompliance: Devices
October 13, 2009VAICenter for Devices and Radiological HealthCompliance: Devices
Other documents for D. O. Weaver and Company
  • FDA Inspection 995563 - 2016-11-10
  • FDA Inspection 625093 - 2009-10-13

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