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FDA Inspection
•Deringer-Ney, Inc.•April 12, 2019

Deringer-Ney, Inc. – FDA Inspection, Apr 12, 2019

Record Details

This FDA Inspection record concerns Deringer-Ney, Inc., with an inspection on April 12, 2019, issued by the Center for Devices and Radiological Health, covering devices.

Company
Deringer-Ney, Inc.
Inspection Date
April 12, 2019
Product Type
Devices
Office
Center for Devices and Radiological Health
Person
  • Eric C. Schmitt (Issuing Officer)
View Company Profile

ID · c0a358bc-93e7-4595-83d3-8d20697d2c1a

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
1086270
FDA center
Medical Devices & Rad Health
Project area
Compliance: Devices
Outcome
Form 483 issued

FDA Citations

2
  1. 21 CFR 820.72(b)Remedial action - documentation
  2. 21 CFR 820.25(b)Training records

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Deringer-Ney, Inc.

2
DateClassificationOfficeProject area
February 12, 2014VAICenter for Devices and Radiological HealthCompliance: Devices
July 12, 2011NAICenter for Devices and Radiological HealthCompliance: Devices
Other documents for Deringer-Ney, Inc.
  • FDA Inspection 871476 - 2014-02-12
  • FDA Inspection 734145 - 2011-07-12

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