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FDA Inspection
•Biomedical Systems Corp•November 17, 2016

Biomedical Systems Corp – FDA Inspection, Nov 17, 2016

Record Details

This FDA Inspection record concerns Biomedical Systems Corp, with an inspection on November 17, 2016, issued by the Center for Drug Evaluation and Research, covering drugs.

Company
Biomedical Systems Corp
Inspection Date
November 17, 2016
Product Type
Drugs
Office
Center for Drug Evaluation and Research
People
  • Karen M. Montgomery (Company Rep)
  • Kathleen B. Swat (FDA Associated Person)
View Company Profile

ID · 242496cf-98ec-4b15-af14-373fa7bf5858

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
994387
FDA center
Human Drugs
Project area
Bioresearch Monitoring
Outcome
Form 483 issued

Other FDA inspections of Biomedical Systems Corp

4
DateClassificationOfficeProject area
April 10, 2017NAICenter for Devices and Radiological HealthCompliance: Devices
March 26, 2015NAICenter for Drug Evaluation and ResearchBioresearch Monitoring
November 28, 2012NAICenter for Devices and Radiological HealthCompliance: Devices
January 12, 2010NAICenter for Drug Evaluation and ResearchBioresearch Monitoring
Other documents for Biomedical Systems Corp
  • FDA Inspection 1008329 - 2017-04-10
  • FDA Inspection 919734 - 2015-03-26
  • FDA Inspection 808520 - 2012-11-28
  • FDA Inspection 639650 - 2010-01-12

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