Form 483

Azile Inc. Form 483, 2017-09-06

FDA issued a Form 483 to Azile Inc. on 2017-09-06 with 1 public-safe observation.

483· Form 483 issuedFoods & Cosmetics1 observation

Azile Inc. · Santa Ana, United States · Issued September 6, 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.

6 Sep 2017
21 CFR 1.511(c)(2)(i)

No CGMPs - approval procedures

Cited by Jeannie Pradyanata

Inspected site

AIAzile Inc.Santa Ana, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 1.511(c)(2)(i)Cited across public-safe Form 483 observations1x

Full 483 report

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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