Form 483

Golden State Medical Supply Inc. Form 483, 2010-12-15

FDA issued a Form 483 to Golden State Medical Supply Inc. on 2010-12-15 with 4 public-safe observations.

483· Form 483 issued4 observations

Golden State Medical Supply Inc. · Camarillo, United States · Issued December 15, 2010

Overview

  • 4 public-safe observations are available for this inspection.
  • 4 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.

15 Dec 2010
21 CFR 211.67(a)

Cleaning / Sanitizing / Maintenance

Cited by Linda Thai

15 Dec 2010
21 CFR 211.67(b)

Written procedures fail to include

Cited by Linda Thai

15 Dec 2010
21 CFR 211.170(b)

Investigation of reserve sample deterioration

Cited by Linda Thai

15 Dec 2010
21 CFR 211.204

Returned drug procedures in writing and followed

Cited by Linda Thai

Inspected site

GSGolden State Medical Supply Inc.Camarillo, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.170(b)Cited across public-safe Form 483 observations1x
21 CFR 211.204Cited across public-safe Form 483 observations1x
21 CFR 211.67(a)Cited across public-safe Form 483 observations1x
21 CFR 211.67(b)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 4 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