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FDA Inspection
•SRI Healthcare LLC•January 12, 2023

SRI Healthcare LLC – FDA Inspection, Jan 12, 2023

Record Details

This FDA Inspection record concerns SRI Healthcare LLC, with an inspection on January 12, 2023, issued by the Center for Devices and Radiological Health, covering devices.

Company
SRI Healthcare LLC
Inspection Date
January 12, 2023
Product Type
Devices
Office
Center for Devices and Radiological Health
Person
  • Jamie P. Webb (Issuing Officer)
View Company Profile

ID · e59879d5-50c0-4626-bfd8-71d4e06fc987

Inspection Facts

No Action Indicated (NAI)

No objectionable conditions or practices were found during the inspection.

Inspection number
1195238
FDA center
Medical Devices & Rad Health
Project area
Postmarket Assurance: Devices
Outcome
Form 483 issued

FDA Citations

1
  1. 21 CFR 820.70(a)Process control procedures, Lack of or inadequate procedures

Full citation text and observation details available on the Dashboard.

Other FDA inspections of SRI Healthcare LLC

3
DateClassificationOfficeProject area
October 30, 2014NAICenter for Devices and Radiological HealthCompliance: Devices
August 16, 2012NAICenter for Devices and Radiological HealthCompliance: Devices
April 28, 2009NAICenter for Devices and Radiological HealthCompliance: Devices
Other documents for SRI Healthcare LLC
  • FDA Inspection 901231 - 2014-10-30
  • FDA Inspection 797597 - 2012-08-16
  • FDA Inspection 578595 - 2009-04-28

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