Form 483

A.I.G Technologies Inc. Form 483, 2011-07-01

FDA issued a Form 483 to A.I.G Technologies Inc. on 2011-07-01 with 9 public-safe observations.

483· Form 483 issued9 observations

A.I.G Technologies Inc. · Deerfield Beach, United States · Issued July 1, 2011

Overview

  • 9 public-safe observations are available for this inspection.
  • 9 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.

1 Jul 2011
21 CFR 211.22(a)

Lack of quality control unit

Cited by Kimberly M Hull

1 Jul 2011
21 CFR 211.25(a)

Training--operations, GMPs, written procedures

Cited by Kimberly M Hull

1 Jul 2011
21 CFR 211.28(b)

Habits of good sanitation & health

Cited by Kimberly M Hull

1 Jul 2011
21 CFR 211.67(c)

Cleaning/maintenance records not kept

Cited by Kimberly M Hull

1 Jul 2011
21 CFR 211.84(a)

Components withheld from use pending release

Cited by Kimberly M Hull

Inspected site

ATA.I.G Technologies Inc.Deerfield Beach, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.100(a)Cited across public-safe Form 483 observations1x
21 CFR 211.113(a)Cited across public-safe Form 483 observations1x
21 CFR 211.134(c)Cited across public-safe Form 483 observations1x
21 CFR 211.182Cited across public-safe Form 483 observations1x
21 CFR 211.22(a)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 211.67(c)Cited across public-safe Form 483 observations1x
21 CFR 211.84(a)Cited across public-safe Form 483 observations1x

Source document

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PDF available

Form 483 source document

The source document is available to authorized Atlas users.

Full 483 report

Get the verbatim text of all 9 observations

The source PDF and 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