Form 483

Awesome Foods, Inc. Form 483, 2014-07-22

FDA issued a Form 483 to Awesome Foods, Inc. on 2014-07-22 with 5 public-safe observations.

483· Form 483 issuedFoods & Cosmetics5 observations

Awesome Foods, Inc. · Norristown, United States · Issued July 22, 2014

Overview

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

Inspectional observations

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

22 Jul 2014
21 CFR 110.10(b)(1)

Suitable outer garments

Cited by Joseph S Fanelli, Daniel W Johnson, Brian D Young, Matthew R Noonan

22 Jul 2014
21 CFR 110.10(b)(4)

Unsecured jewelry

Cited by Joseph S Fanelli, Daniel W Johnson, Brian D Young, Matthew R Noonan

22 Jul 2014
21 CFR 110.10(b)(9)

Precautions against contamination--micro, foreign substances

Cited by Joseph S Fanelli, Daniel W Johnson, Brian D Young, Matthew R Noonan

22 Jul 2014
21 CFR 110.35(a)

Cleaning and sanitizing operations

Cited by Joseph S Fanelli, Daniel W Johnson, Brian D Young, Matthew R Noonan

22 Jul 2014
21 CFR 110.35(b)(2)

Storage requirements

Cited by Joseph S Fanelli, Daniel W Johnson, Brian D Young, Matthew R Noonan

Inspected site

AFAwesome Foods, Inc.Norristown, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 110.10(b)(1)Cited across public-safe Form 483 observations1x
21 CFR 110.10(b)(4)Cited across public-safe Form 483 observations1x
21 CFR 110.10(b)(9)Cited across public-safe Form 483 observations1x
21 CFR 110.35(a)Cited across public-safe Form 483 observations1x
21 CFR 110.35(b)(2)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 5 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