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FDA Inspection
•Alvarez, Dr Jorge•August 15, 2014

Alvarez, Dr Jorge – FDA Inspection, Aug 15, 2014

Record Details

This FDA Inspection record concerns Alvarez, Dr Jorge, with an inspection on August 15, 2014, issued by the Center for Drug Evaluation and Research, covering drugs.

Company
Alvarez, Dr Jorge
Inspection Date
August 15, 2014
Product Type
Drugs
Office
Center for Drug Evaluation and Research
View Company Profile

ID · 6464a064-333c-49c8-af15-83c0942105d4

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
891180
FDA center
Human Drugs
Project area
Bioresearch Monitoring

FDA Citations

3
  1. 21 CFR 312.60FD-1572, protocol compliance
  2. 21 CFR 312.62(b)Case history records- inadequate or inadequate
  3. 21 CFR 50.27(a)Consent form not approved/signed/dated

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