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FDA Inspection
•Stryker Corporation•March 14, 2012

Stryker Corporation – FDA Inspection, Mar 14, 2012

Record Details

This FDA Inspection record concerns Stryker Corporation, with an inspection on March 14, 2012, issued by the Center for Devices and Radiological Health, covering devices.

Company
Stryker Corporation
Inspection Date
March 14, 2012
Product Type
Devices
Office
Center for Devices and Radiological Health
View Company Profile

ID · 2a30a536-c422-48e5-8a74-4b8a4d8b0331

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
772257
FDA center
Medical Devices & Rad Health
Project area
Postmarket Assurance: Devices

FDA Citations

3
  1. 21 CFR 803.50(a)(2)Individual Report of Malfunction
  2. 21 CFR 820.72(a)Calibration, Inspection, etc. Procedures Lack of or Inadequ
  3. 21 CFR 820.184DHR content

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Stryker Corporation

7
DateClassificationOfficeProject area
November 21, 2019NAICenter for Devices and Radiological HealthPostmarket Assurance: Devices
May 25, 2018Not classifiedSan Francisco District Office
August 25, 2016NAICenter for Devices and Radiological HealthCompliance: Devices
September 18, 2015NAICenter for Devices and Radiological HealthPostmarket Assurance: Devices
October 8, 2014VAICenter for Devices and Radiological HealthCompliance: Devices
View all 7 other inspections on the company page
Other documents for Stryker Corporation
  • FDA Inspection 1110636 - 2019-11-21
  • FDA Inspection 1077335 - 2018-05-25
  • FDA Inspection 981779 - 2016-08-25
  • FDA Inspection 943626 - 2015-09-18
  • FDA Inspection 896766 - 2014-10-08

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