Form 483

LEA FOODS Form 483, 2022-08-17

FDA issued a Form 483 to LEA FOODS on 2022-08-17 with 5 public-safe observations.

483· Form 483 issuedFoods & Cosmetics5 observations

LEA FOODS · Elk Grove Village, United States · Issued August 17, 2022

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.

17 Aug 2022
21 CFR 1.502(a)

Develop FSVP

Cited by Karla J Youngberg

17 Aug 2022
21 CFR 1.504(b)(1)

Hazard analysis biological, chemical, physical

Cited by Karla J Youngberg

17 Aug 2022
21 CFR 1.505(c)(2)

Reevaluate - 3 years

Cited by Karla J Youngberg

17 Aug 2022
21 CFR 1.506(d)(1)(i)

Verification activity assurance

Cited by Karla J Youngberg

17 Aug 2022
21 CFR 1.506(d)(2)

Onsite audit

Cited by Karla J Youngberg

Inspected site

LFLEA FOODSElk Grove Village, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 1.502(a)Cited across public-safe Form 483 observations1x
21 CFR 1.504(b)(1)Cited across public-safe Form 483 observations1x
21 CFR 1.505(c)(2)Cited across public-safe Form 483 observations1x
21 CFR 1.506(d)(1)(i)Cited across public-safe Form 483 observations1x
21 CFR 1.506(d)(2)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 5 observations

The full inspection record, as Atlas holds it, 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