Atlas

Form 483

H & L Jerch Sales, Inc. Form 483, 2018-07-09

FDA issued a Form 483 to H & L Jerch Sales, Inc. on 2018-07-09 with 4 public-safe observations.

483· Form 483 issuedFoods & Cosmetics4 observations

H & L Jerch Sales, Inc. · South Haven, United States · Issued July 9, 2018

Overview

  • 4 public-safe observations are available for this inspection.
  • 4 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.

9 Jul 2018
21 CFR 111.12

Personnel - quality control personnel - qualified

Cited by Theodore N Sietsema, Chelsea J Falkowski, Chelsea J Snider

9 Jul 2018
21 CFR 111.560(a)(1)

Product complaint - quality control review

Cited by Theodore N Sietsema, Chelsea J Falkowski, Chelsea J Snider

9 Jul 2018
21 CFR 111.105(d)

Quality control - basis; tests, examinations

Cited by Theodore N Sietsema, Chelsea J Falkowski, Chelsea J Snider

9 Jul 2018
21 CFR 111.410(b)

Packaging - issuance, use

Cited by Theodore N Sietsema, Chelsea J Falkowski, Chelsea J Snider

Inspected site

H&H & L Jerch Sales, Inc.South Haven, United States

Inspection team

TNTheodore N Sietsema
CJChelsea J Falkowski
CJChelsea J Snider

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 111.105(d)Cited across public-safe Form 483 observations1x
21 CFR 111.12Cited across public-safe Form 483 observations1x
21 CFR 111.410(b)Cited across public-safe Form 483 observations1x
21 CFR 111.560(a)(1)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 4 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