Form 483

Lipari Foods Operating Company LLC DBA JLM Manufacturing LLC Form 483, 2019-09-12

FDA issued a Form 483 to Lipari Foods Operating Company LLC DBA JLM Manufacturing LLC on 2019-09-12 with 3 public-safe observations.

483· Form 483 issuedFoods & Cosmetics3 observations

Lipari Foods Operating Company LLC DBA JLM Manufacturing LLC · Warren, United States · Issued September 12, 2019

Overview

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

Inspectional observations

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

12 Sep 2019
21 CFR 117.145(a)

Allergen Controls Monitoring Proced: Establish Implement

Cited by Marlon K Turner, John N Woodall, Rasha Bamieh, Claire O Nicholls

12 Sep 2019
21 CFR 117.145(a)

Sanitation Controls Monitoring Proced: Establish Implement

Cited by Marlon K Turner, John N Woodall, Rasha Bamieh, Claire O Nicholls

12 Sep 2019
21 CFR 117.150(a)(1)

Sanitation Controls Corrective Action Proced: Estab Implemnt

Cited by Marlon K Turner, John N Woodall, Rasha Bamieh, Claire O Nicholls

Inspected site

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 117.145(a)Cited across public-safe Form 483 observations2x
21 CFR 117.150(a)(1)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 3 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