Atlas

Form 483

Gilead Sciences, Inc. Form 483, 2009-12-04

FDA issued a Form 483 to Gilead Sciences, Inc. on 2009-12-04 with 3 public-safe observations.

483· Form 483 issued3 observations

Gilead Sciences, Inc. · Foster City, United States · Issued December 4, 2009

Overview

  • 3 public-safe observations are available for this inspection.
  • 3 structured CFR citations are represented.
  • 1 investigator is tied to this Form 483.

Inspectional observations

Each observation cites the regulation FDA found the firm out of compliance with.

4 Dec 2009
21 CFR 211.22(d)

Procedures not in writing, fully followed

Cited by Lance M De Souza

4 Dec 2009
21 CFR 211.160(a)

Deviations from laboratory control requirements

Cited by Lance M De Souza

4 Dec 2009
21 CFR 211.180(e)

Records reviewed annually

Cited by Lance M De Souza

Inspected site

GSGilead Sciences, Inc.Foster City, United States

Inspection team

LMLance M De Souza

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.160(a)Cited across public-safe Form 483 observations1x
21 CFR 211.180(e)Cited across public-safe Form 483 observations1x
21 CFR 211.22(d)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 3 observations

Every observation in full, so your team sees exactly what was cited and how it was answered.

  • The site's full inspection history around this Form 483
  • Whether these citations escalated to a warning letter
  • The investigators involved and the citations they repeat elsewhere