Form 483

Ally K Enterprise Corp. Form 483, 2012-09-21

FDA issued a Form 483 to Ally K Enterprise Corp. on 2012-09-21 with 2 public-safe observations.

483· Form 483 issued2 observations

Ally K Enterprise Corp. · Doral, United States · Issued September 21, 2012

Overview

  • 2 public-safe observations are available for this inspection.
  • 2 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.

21 Sep 2012
21 CFR 123.6(b)

HACCP plan implementation

Cited by Gabriel E Muniz

21 Sep 2012
21 CFR 123.6(c)(3)

Critical limits

Cited by Gabriel E Muniz

Inspected site

AKAlly K Enterprise Corp.Doral, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 123.6(b)Cited across public-safe Form 483 observations1x
21 CFR 123.6(c)(3)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 2 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