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FDA Inspection
•Gilead Sciences, Inc.•July 17, 2018

Gilead Sciences, Inc. – FDA Inspection, Jul 17, 2018

Record Details

This FDA Inspection record concerns Gilead Sciences, Inc., with an inspection on July 17, 2018, issued by the Center for Drug Evaluation and Research, covering drugs.

Company
Gilead Sciences, Inc.
Inspection Date
July 17, 2018
Product Type
Drugs
Office
Center for Drug Evaluation and Research
People
  • Diane C. Van Leeuwen (Company Rep)
  • Dustin R. Abaonza (Company Rep)
View Company Profile

ID · a7c9d301-177d-4aa7-accc-64106381e6fa

Inspection Facts

Voluntary Action Indicated (VAI)

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

Inspection number
1065316
FDA center
Human Drugs
Project area
Postmarket Surv. and Epidemiology
Outcome
Form 483 issued

FDA Citations

1
  1. 21 CFR 314.80(c)(1)(i)Late submission of 15-day report

Full citation text and observation details available on the Dashboard.

Other FDA inspections of Gilead Sciences, Inc.

16
DateClassificationOfficeProject area
January 16, 2026NAIBioresearch Monitoring
January 29, 2025Not classifiedSan Francisco District Office
January 22, 2024VAICenter for Drug Evaluation and ResearchBioresearch Monitoring
August 18, 2020NAICenter for Drug Evaluation and ResearchBioresearch Monitoring
July 22, 2020VAICenter for Drug Evaluation and ResearchBioresearch Monitoring
View all 16 other inspections on the company page
Other documents for Gilead Sciences, Inc.
  • FDA Inspection 1300496 - 2026-01-16
  • FDA Inspection 1258330 - 2025-01-29
  • FDA Inspection 1227801 - 2024-01-22
  • FDA Inspection 1128174 - 2020-08-18
  • FDA Inspection 1125580 - 2020-07-22

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