Form 483

All Over Import & Export, Inc. Form 483, 2010-01-22

FDA issued a Form 483 to All Over Import & Export, Inc. on 2010-01-22 with 8 public-safe observations.

483· Form 483 issued8 observations

All Over Import & Export, Inc. · Miami, United States · Issued January 22, 2010

Overview

  • 8 public-safe observations are available for this inspection.
  • 8 structured CFR citations are represented.
  • 3 investigators are tied to this Form 483.

Inspectional observations

Each observation cites the regulation FDA found the firm out of compliance with.

22 Jan 2010
21 CFR 110.10(b)(2)

Personal cleanliness

Cited by Nicole M Bell, Kathleen V Ferguson, Mark V Preciados

22 Jan 2010
21 CFR 110.10(b)(3)

Not washed/sanitized when appropriate

Cited by Nicole M Bell, Kathleen V Ferguson, Mark V Preciados

22 Jan 2010
21 CFR 110.10(b)(9)

Precautions against contamination--micro, foreign substances

Cited by Nicole M Bell, Kathleen V Ferguson, Mark V Preciados

22 Jan 2010
21 CFR 110.20(b)(7)

Screening

Cited by Nicole M Bell, Kathleen V Ferguson, Mark V Preciados

22 Jan 2010
21 CFR 110.35(a)

Cleaning and sanitizing operations

Cited by Nicole M Bell, Kathleen V Ferguson, Mark V Preciados

Inspected site

AOAll Over Import & Export, Inc.Miami, United States

Inspection team

KVKathleen V Ferguson

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 110.10(b)(2)Cited across public-safe Form 483 observations1x
21 CFR 110.10(b)(3)Cited across public-safe Form 483 observations1x
21 CFR 110.10(b)(9)Cited across public-safe Form 483 observations1x
21 CFR 110.20(b)(7)Cited across public-safe Form 483 observations1x
21 CFR 110.35(a)Cited across public-safe Form 483 observations1x
21 CFR 110.35(c)Cited across public-safe Form 483 observations1x
21 CFR 110.35(d)(5)Cited across public-safe Form 483 observations1x
21 CFR 110.35(e)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 8 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