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FDA Inspection
•TCR Medical Corporation•October 24, 2016

TCR Medical Corporation – FDA Inspection, Oct 24, 2016

Record Details

This FDA Inspection record concerns TCR Medical Corporation, with an inspection on October 24, 2016, issued by the Los Angeles District Office, covering human drugs.

Company
TCR Medical Corporation
Inspection Date
October 24, 2016
Product Type
Human Drugs
Office
Los Angeles District Office
Person
  • Sara J. Dent Acosta
View Company Profile

ID · bc3a59c8-5ee1-4655-817c-6a44d5c0c54f

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
991559
FDA center
Human Drugs
Project area
Bioresearch Monitoring
Outcome
Form 483 issued

FDA Citations

1
  1. 21 CFR 312.62(b)Case history records- inadequate or inadequate

Full citation text and observation details available on the Dashboard.

Other FDA inspections of TCR Medical Corporation

1
DateClassificationOfficeProject area
December 16, 2011NAICenter for Devices and Radiological HealthBioresearch Monitoring
Other documents for TCR Medical Corporation
  • FDA Inspection 760158 - 2011-12-16

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