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FDA Inspection
•PATH•January 26, 2010

PATH – FDA Inspection, Jan 26, 2010

Record Details

This FDA Inspection record concerns PATH, with an inspection on January 26, 2010, issued by the Center for Drug Evaluation and Research, covering drugs.

Company
PATH
Inspection Date
January 26, 2010
Product Type
Drugs
Office
Center for Drug Evaluation and Research
View Company Profile

ID · 4ae43d64-7e38-44cf-b8b1-352a44a75705

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
639147
FDA center
Human Drugs
Project area
Bioresearch Monitoring

FDA Citations

3
  1. 21 CFR 50.25(a)(2)Reasonably foreseeable risks or discomforts
  2. 21 CFR 56.108(a)(1)Reporting findings and actions to investigator/institution
  3. 21 CFR 50.25(a)(5)Confidentiality, FDA inspection of records

Full citation text and observation details available on the Dashboard.

Other FDA inspections of PATH

1
DateClassificationOfficeProject area
October 16, 2015NAICenter for Biologics Evaluation and ResearchBioresearch Monitoring
Other documents for PATH
  • FDA Inspection 945729 - 2015-10-16

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