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Form 483

G&E Asian American Ent. Inc. Form 483, 2017-08-25

FDA issued a Form 483 to G&E Asian American Ent. Inc. on 2017-08-25 with 1 public-safe observation.

483· Form 483 issuedFoods & Cosmetics1 observation

G&E Asian American Ent. Inc. · Garden Grove, United States · Issued August 25, 2017

Overview

  • 1 public-safe observation is available for this inspection.
  • 1 structured CFR citation is represented.
  • 1 investigator is tied to this Form 483.

Inspectional observations

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

25 Aug 2017
21 CFR 1.512(b)(2)

Develop FSVP

Cited by Misty L Wallace

Inspected site

GAG&E Asian American Ent. Inc.Garden Grove, United States

Inspection team

MLMisty L Wallace

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 1.512(b)(2)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 1 observation

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