Form 483

Absolute Packaging, Inc. Form 483, 2010-04-09

FDA issued a Form 483 to Absolute Packaging, Inc. on 2010-04-09 with 26 public-safe observations.

483· Form 483 issued26 observations

Absolute Packaging, Inc. · Melbourne, United States · Issued April 9, 2010

Overview

  • 26 public-safe observations are available for this inspection.
  • 25 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.

9 Apr 2010
21 CFR 211.22(a)

Contract drug products--lack of responsibility

Cited by Kimberly M Hull

9 Apr 2010
21 CFR 211.22(d)

Procedures not in writing, fully followed

Cited by Kimberly M Hull

9 Apr 2010
21 CFR 211.25(a)

Training--operations, GMPs, written procedures

Cited by Kimberly M Hull

9 Apr 2010
21 CFR 211.28(b)

Habits of good sanitation & health

Cited by Kimberly M Hull

9 Apr 2010
21 CFR 211.56(c)

Written procedures lacking for use of pesticides etc.

Cited by Kimberly M Hull

Inspected site

APAbsolute Packaging, Inc.Melbourne, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.160(a)Cited across public-safe Form 483 observations2x
21 CFR 211.100(a)Cited across public-safe Form 483 observations1x
21 CFR 211.105(b)Cited across public-safe Form 483 observations1x
21 CFR 211.125(a)Cited across public-safe Form 483 observations1x
21 CFR 211.160(b)(4)Cited across public-safe Form 483 observations1x
21 CFR 211.165(c)Cited across public-safe Form 483 observations1x
21 CFR 211.165(d)Cited across public-safe Form 483 observations1x
21 CFR 211.165(e)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 211.180(e)Cited across public-safe Form 483 observations1x
21 CFR 211.188(b)(7)Cited across public-safe Form 483 observations1x
21 CFR 211.194(a)(5)Cited across public-safe Form 483 observations1x
21 CFR 211.194(a)(8)Cited across public-safe Form 483 observations1x
21 CFR 211.198(a)Cited across public-safe Form 483 observations1x
21 CFR 211.22(a)Cited across public-safe Form 483 observations1x
21 CFR 211.22(d)Cited across public-safe Form 483 observations1x
21 CFR 211.25(a)Cited across public-safe Form 483 observations1x
21 CFR 211.28(b)Cited across public-safe Form 483 observations1x
21 CFR 211.56(c)Cited 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
21 CFR 211.68(b)Cited across public-safe Form 483 observations1x
21 CFR 211.84(d)(1)Cited across public-safe Form 483 observations1x
21 CFR 211.87Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 26 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