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FDA Inspection
•Biosearch Medical Products, Inc.•November 19, 2009

Biosearch Medical Products, Inc. – FDA Inspection, Nov 19, 2009

Record Details

This FDA Inspection record concerns Biosearch Medical Products, Inc., with an inspection on November 19, 2009, issued by the Center for Devices and Radiological Health, covering devices.

Company
Biosearch Medical Products, Inc.
Inspection Date
November 19, 2009
Product Type
Devices
Office
Center for Devices and Radiological Health
View Company Profile

ID · eff1090b-dd1a-42ba-949b-38a99aed056f

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
629685
FDA center
Medical Devices & Rad Health
Project area
Postmarket Assurance: Devices

FDA Citations

4
  1. 21 CFR 820.100(a)(1)Analysis of data/reports from data sources
  2. 21 CFR 820.90(a)Nonconforming product, Lack of or inadequate procedures
  3. 21 CFR 820.100(a)Lack of or inadequate procedures
  4. 21 CFR 803.17(a)(2)Lack of System for Determining MDR Events

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Biosearch Medical Products, Inc.

4
DateClassificationOfficeProject area
October 11, 2022NAICenter for Devices and Radiological HealthCompliance: Devices
March 23, 2018NAICenter for Devices and Radiological HealthCompliance: Devices
November 5, 2014NAICenter for Devices and Radiological HealthPostmarket Assurance: Devices
December 1, 2011NAICenter for Devices and Radiological HealthCompliance: Devices
Other documents for Biosearch Medical Products, Inc.
  • FDA Inspection 1181545 - 2022-10-11
  • FDA Inspection 1054288 - 2018-03-23
  • FDA Inspection 903153 - 2014-11-05
  • FDA Inspection 756112 - 2011-12-01

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