Form 483

Hills Supply Inc Form 483, 2009-06-17

FDA issued a Form 483 to Hills Supply Inc on 2009-06-17 with 10 public-safe observations.

483· Form 483 issued10 observations

Hills Supply Inc · Canal Fulton, United States · Issued June 17, 2009

Overview

  • 10 public-safe observations are available for this inspection.
  • 10 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.

17 Jun 2009
21 CFR 211.68(a)

Written calibration / inspection records not kept

Cited by Janet L Bowen

17 Jun 2009
21 CFR 211.80(a)

Procedures To Be in Writing

Cited by Janet L Bowen

17 Jun 2009
21 CFR 211.122(a)

Written procedures not followed

Cited by Janet L Bowen

17 Jun 2009
21 CFR 211.122(d)

Labels and labeling stored separately

Cited by Janet L Bowen

17 Jun 2009
21 CFR 211.122(g)(3)

Visual inspection

Cited by Janet L Bowen

Inspected site

HSHills Supply IncCanal Fulton, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.122(a)Cited across public-safe Form 483 observations1x
21 CFR 211.122(d)Cited across public-safe Form 483 observations1x
21 CFR 211.122(g)(3)Cited across public-safe Form 483 observations1x
21 CFR 211.165(a)Cited across public-safe Form 483 observations1x
21 CFR 211.166(a)(4)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 211.194(a)(5)Cited across public-safe Form 483 observations1x
21 CFR 211.68(a)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 10 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