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FDA Inspection
•Nelson-Miller•February 18, 2015

Nelson-Miller – FDA Inspection, Feb 18, 2015

Record Details

This FDA Inspection record concerns Nelson-Miller, with an inspection on February 18, 2015, issued by the Center for Devices and Radiological Health, covering devices.

Company
Nelson-Miller
Inspection Date
February 18, 2015
Product Type
Devices
Office
Center for Devices and Radiological Health
View Company Profile

ID · 621d3b21-b40e-42c9-a668-3dc9d762c451

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
915188
FDA center
Medical Devices & Rad Health
Project area
Compliance: Devices

FDA Citations

6
  1. 21 CFR 820.100(b)Documentation
  2. 21 CFR 820.40Procedures not adequately established or maintained
  3. 21 CFR 820.80(b)Lack of or inadequate receiving acceptance procedures
  4. 21 CFR 820.198(a)Lack of or inadequate complaint procedures
  5. 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
  6. 21 CFR 820.75(c)Documentation - review in response to changes or deviations

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Nelson-Miller

1
DateClassificationOfficeProject area
November 18, 2011VAICenter for Devices and Radiological HealthCompliance: Devices
Other documents for Nelson-Miller
  • FDA Inspection 753952 - 2011-11-18

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