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FDA Inspection
•Aprios Custom Mfg•February 7, 2025

FDA Inspection 1260276 - Aprios Custom Mfg - February 07, 2025

Record Details

This FDA Inspection record concerns Aprios Custom Mfg, with an inspection on February 7, 2025, issued by the Minneapolis District Office, covering medical devices & rad health.

Company
Aprios Custom Mfg
Inspection Date
February 7, 2025
Product Type
Medical Devices & Rad Health
Office
Minneapolis District Office
Person
  • Alicia U. Jacobo (Investigator)
View Company Profile

ID · b13de0ae-0048-471a-bb57-de8080921aeb

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
1260276
FDA center
Medical Devices & Rad Health
Project area
Compliance: Medical Devices
Outcome
Form 483 issued

FDA Citations

1
  1. 21 CFR 820.198(e)Maintained

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Aprios Custom Mfg

3
DateClassificationOfficeProject area
March 30, 2022NAICenter for Devices and Radiological HealthCompliance: Devices
April 4, 2018NAICenter for Devices and Radiological HealthCompliance: Devices
January 7, 2014NAICenter for Devices and Radiological HealthCompliance: Devices
Other documents for Aprios Custom Mfg
  • FDA Inspection 1166867 - 2022-03-30
  • FDA Inspection 1049446 - 2018-04-04
  • FDA Inspection 862434 - 2014-01-07

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