Form 483

Ally K Enterprise Corp. Form 483, 2009-08-04

FDA issued a Form 483 to Ally K Enterprise Corp. on 2009-08-04 with 2 public-safe observations.

483· Form 483 issued2 observations

Ally K Enterprise Corp. · Doral, United States · Issued August 4, 2009

Overview

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

Inspectional observations

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

4 Aug 2009

21 CFR 123.6(b)

No HACCP plan

Cited by Edwin J Gorney, Nyvia R Burgos

4 Aug 2009

21 CFR 123.12(a)(2)

Importer verification

Cited by Edwin J Gorney, Nyvia R Burgos

Inspected site

AKAlly K Enterprise Corp.Doral, United States

Inspection team

EJEdwin J Gorney

NRNyvia R Burgos

Cited regulations

CFR citations associated with this Form 483.

Citation	What it covers	Cited
21 CFR 123.12(a)(2)	Cited across public-safe Form 483 observations	1x
21 CFR 123.6(b)	Cited across public-safe Form 483 observations	1x

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