Form 483

Swanel Beverage, Inc Form 483, 2013-03-29

FDA issued a Form 483 to Swanel Beverage, Inc on 2013-03-29 with 4 public-safe observations.

483· Form 483 issuedFoods & Cosmetics4 observations

Swanel Beverage, Inc · Hammond, United States · Issued March 29, 2013

Overview

  • 4 public-safe observations are available for this inspection.
  • 4 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.

29 Mar 2013
21 CFR 110.80(b)(7)

Equipment, containers, utensils

Cited by Margaret N Persich

29 Mar 2013
21 CFR 120.6(c)

SSOP records

Cited by Margaret N Persich

29 Mar 2013
21 CFR 120.8(a)

No HACCP plan

Cited by Margaret N Persich

29 Mar 2013
21 CFR 120.24(c)

Process controls - not exempt, single facility

Cited by Margaret N Persich

Inspected site

SBSwanel Beverage, IncHammond, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 110.80(b)(7)Cited across public-safe Form 483 observations1x
21 CFR 120.24(c)Cited across public-safe Form 483 observations1x
21 CFR 120.6(c)Cited across public-safe Form 483 observations1x
21 CFR 120.8(a)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 4 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