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FDA Inspection
•North Coast Medical Inc•November 30, 2016

North Coast Medical Inc – FDA Inspection, Nov 30, 2016

Record Details

This FDA Inspection record concerns North Coast Medical Inc, with an inspection on November 30, 2016, issued by the San Francisco District Office, covering medical devices & rad health.

Company
North Coast Medical Inc
Inspection Date
November 30, 2016
Product Type
Medical Devices & Rad Health
Office
San Francisco District Office
People
  • James A. Lane (FDA Associated Person)
  • Sara M. Onyango (Issuing Officer)
View Company Profile

ID · 632782e5-ffe2-472f-b2fd-31d29bf8cd96

Inspection Facts

Inspection number
997734
FDA center
Medical Devices & Rad Health
Project area
Postmarket Assurance: Devices
Outcome
Form 483 issued

FDA Citations

4
  1. 21 CFR 803.50(a)(1)Report of Death or Serious Injury
  2. 21 CFR 820.100(b)Documentation
  3. 21 CFR 820.20(c)Management review dates
  4. 21 CFR 820.25(b)Training records

Full citation text and observation details available on the Dashboard.

Other FDA inspections of North Coast Medical Inc

6
DateClassificationOfficeProject area
August 2, 2024VAICenter for Devices and Radiological HealthCompliance: Devices
August 28, 2023VAICenter for Devices and Radiological HealthPostmarket Assurance: Devices
April 24, 2012NAICenter for Devices and Radiological HealthCompliance: Devices
February 24, 2012VAICenter for Devices and Radiological HealthCompliance: Devices
May 25, 2011OAICenter for Devices and Radiological HealthCompliance: Devices
View all 6 other inspections on the company page
Other documents for North Coast Medical Inc
  • FDA Inspection 1245520 - 2024-08-02
  • FDA Inspection 1216094 - 2023-08-28
  • FDA Inspection 778263 - 2012-04-24
  • FDA Inspection 771852 - 2012-02-24
  • FDA Inspection 727010 - 2011-05-25

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Contact
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