Form 483

Golden State Medical Supply Inc. Form 483, 2011-02-02

FDA issued a Form 483 to Golden State Medical Supply Inc. on 2011-02-02 with 11 public-safe observations.

483· Form 483 issued11 observations

Golden State Medical Supply Inc. · Camarillo, United States · Issued February 2, 2011

Overview

  • 11 public-safe observations are available for this inspection.
  • 11 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.

2 Feb 2011
21 CFR 211.67(b)

Written procedures not established/followed

Cited by Sonia R Peterson

2 Feb 2011
21 CFR 211.80(a)

Procedures To Be in Writing

Cited by Sonia R Peterson

2 Feb 2011
21 CFR 211.122(d)

Label storage access limited to authorized personnel

Cited by Sonia R Peterson

2 Feb 2011
21 CFR 211.137(a)

Expiration date lacking

Cited by Sonia R Peterson

2 Feb 2011
21 CFR 211.142

Written warehousing procedures established/followed

Cited by Sonia R Peterson

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 211.122(d)Cited across public-safe Form 483 observations1x
21 CFR 211.137(a)Cited across public-safe Form 483 observations1x
21 CFR 211.142Cited across public-safe Form 483 observations1x
21 CFR 211.165(c)Cited across public-safe Form 483 observations1x
21 CFR 211.166(a)Cited across public-safe Form 483 observations1x
21 CFR 211.170(b)Cited across public-safe Form 483 observations1x
21 CFR 211.184(c)Cited across public-safe Form 483 observations1x
21 CFR 211.192Cited across public-safe Form 483 observations1x
21 CFR 211.198(a)Cited across public-safe Form 483 observations1x
21 CFR 211.67(b)Cited across public-safe Form 483 observations1x
21 CFR 211.80(a)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 11 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