Form 483

LODC, Inc. Form 483, 2018-05-02

FDA issued a Form 483 to LODC, Inc. on 2018-05-02 with 27 public-safe observations.

483· Form 483 issuedFoods & Cosmetics27 observations

LODC, Inc. · Mercedes, United States · Issued May 2, 2018

Overview

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

2 May 2018
21 CFR 111.205(a)

Master manufacturing record - each batch

Cited by Kibily D Dembele

2 May 2018
21 CFR 111.205(a)

Master manufacturing record - each batch

Cited by Kibily D Dembele

2 May 2018
21 CFR 111.20(h)

Physical plant - screening against pests

Cited by Kibily D Dembele

2 May 2018
21 CFR 111.20(h)

Physical plant - screening against pests

Cited by Kibily D Dembele

2 May 2018
21 CFR 111.210(h)(3)(i)

Components, verify weight, measure

Cited by Kibily D Dembele

Inspected site

LILODC, Inc.Mercedes, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 111.123(a)(1)Cited across public-safe Form 483 observations3x
21 CFR 111.15(c)(3)Cited across public-safe Form 483 observations3x
21 CFR 111.20(h)Cited across public-safe Form 483 observations3x
21 CFR 111.205(a)Cited across public-safe Form 483 observations3x
21 CFR 111.210(g)Cited across public-safe Form 483 observations3x
21 CFR 111.210(h)(3)(i)Cited across public-safe Form 483 observations3x
21 CFR 111.260(c)Cited across public-safe Form 483 observations3x
21 CFR 111.27(a)Cited across public-safe Form 483 observations3x
21 CFR 117.20(b)Cited across public-safe Form 483 observations3x

Full 483 report

Get the verbatim text of all 27 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