Form 483

Cubanita Frozen Foods Corp. Form 483, 2009-03-13

FDA issued a Form 483 to Cubanita Frozen Foods Corp. on 2009-03-13 with 15 public-safe observations.

483· Form 483 issued15 observations

Cubanita Frozen Foods Corp. · Miami, United States · Issued March 13, 2009

Overview

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

Inspectional observations

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

13 Mar 2009
21 CFR 110.10(b)(3)

Not washed/sanitized when appropriate

Cited by Gabriel E Muniz, Teresa I Navas, Edwin J Gorney

13 Mar 2009
21 CFR 110.10(b)(4)

Unsecured jewelry

Cited by Gabriel E Muniz, Teresa I Navas, Edwin J Gorney

13 Mar 2009
21 CFR 110.10(b)(6)

Failure to wear

Cited by Gabriel E Muniz, Teresa I Navas, Edwin J Gorney

13 Mar 2009
21 CFR 110.10(b)(8)

Personal food/drink/tobacco

Cited by Gabriel E Muniz, Teresa I Navas, Edwin J Gorney

13 Mar 2009
21 CFR 110.10(c)

Training of handlers and supervisors

Cited by Gabriel E Muniz, Teresa I Navas, Edwin J Gorney

Inspected site

CFCubanita Frozen Foods Corp.Miami, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 110.10(b)(3)Cited across public-safe Form 483 observations1x
21 CFR 110.10(b)(4)Cited across public-safe Form 483 observations1x
21 CFR 110.10(b)(6)Cited across public-safe Form 483 observations1x
21 CFR 110.10(b)(8)Cited across public-safe Form 483 observations1x
21 CFR 110.10(c)Cited across public-safe Form 483 observations1x
21 CFR 110.20(a)(4)Cited across public-safe Form 483 observations1x
21 CFR 110.20(b)(4)Cited across public-safe Form 483 observations1x
21 CFR 110.20(b)(7)Cited across public-safe Form 483 observations1x
21 CFR 110.35(c)Cited across public-safe Form 483 observations1x
21 CFR 110.37(d)(1)Cited across public-safe Form 483 observations1x
21 CFR 110.37(d)(3)Cited across public-safe Form 483 observations1x
21 CFR 110.80(a)(1)Cited across public-safe Form 483 observations1x
21 CFR 110.80(b)(2)Cited across public-safe Form 483 observations1x
21 CFR 110.80(b)(7)Cited across public-safe Form 483 observations1x
21 CFR 110.93Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 15 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