Form 483

La Real Foods, Inc. Form 483, 2009-10-08

FDA issued a Form 483 to La Real Foods, Inc. on 2009-10-08 with 9 public-safe observations.

483· Form 483 issued9 observations

La Real Foods, Inc. · Miami, United States · Issued October 8, 2009

Overview

  • 9 public-safe observations are available for this inspection.
  • 9 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.

8 Oct 2009
21 CFR 110.10(b)(1)

Suitable outer garments

Cited by Joanne E King, Craig A Garmendia

8 Oct 2009
21 CFR 110.10(b)(5)

Glove condition

Cited by Joanne E King, Craig A Garmendia

8 Oct 2009
21 CFR 110.20(b)(1)

Sufficient space

Cited by Joanne E King, Craig A Garmendia

8 Oct 2009
21 CFR 110.35(a)

Cleaning and sanitizing operations

Cited by Joanne E King, Craig A Garmendia

8 Oct 2009
21 CFR 110.35(b)(2)

Storage requirements

Cited by Joanne E King, Craig A Garmendia

Inspected site

LRLa Real Foods, Inc.Miami, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 110.10(b)(1)Cited across public-safe Form 483 observations1x
21 CFR 110.10(b)(5)Cited across public-safe Form 483 observations1x
21 CFR 110.20(b)(1)Cited across public-safe Form 483 observations1x
21 CFR 110.35(a)Cited across public-safe Form 483 observations1x
21 CFR 110.35(b)(2)Cited across public-safe Form 483 observations1x
21 CFR 110.35(d)Cited across public-safe Form 483 observations1x
21 CFR 110.35(d)(1)Cited across public-safe Form 483 observations1x
21 CFR 110.37(b)(2)Cited across public-safe Form 483 observations1x
21 CFR 110.37(e)(3)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 9 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