Form 483

Pno Confectionery Enterprises Inc Form 483, 2010-03-26

FDA issued a Form 483 to Pno Confectionery Enterprises Inc on 2010-03-26 with 5 public-safe observations.

483· Form 483 issued5 observations

Pno Confectionery Enterprises Inc · Miami, United States · Issued March 26, 2010

Overview

  • 5 public-safe observations are available for this inspection.
  • 5 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.

26 Mar 2010
21 CFR 110.20(a)(1)

Harborage areas

Cited by Gale E Ryan

26 Mar 2010
21 CFR 110.20(b)(7)

Screening

Cited by Gale E Ryan

26 Mar 2010
21 CFR 110.37(a)

Suitable temp. and pressure

Cited by Gale E Ryan

26 Mar 2010
21 CFR 110.37(d)(3)

Self-closing doors

Cited by Gale E Ryan

26 Mar 2010
21 CFR 110.37(e)(2)

Hand cleaning and sanitizing preparations

Cited by Gale E Ryan

Inspected site

PCPno Confectionery Enterprises IncMiami, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 110.20(a)(1)Cited across public-safe Form 483 observations1x
21 CFR 110.20(b)(7)Cited across public-safe Form 483 observations1x
21 CFR 110.37(a)Cited across public-safe Form 483 observations1x
21 CFR 110.37(d)(3)Cited across public-safe Form 483 observations1x
21 CFR 110.37(e)(2)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 5 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