Atlas

Form 483

E&H Distributors Llc Form 483, 2017-09-12

FDA issued a Form 483 to E&H Distributors Llc on 2017-09-12 with 2 public-safe observations.

483· Form 483 issuedFoods & Cosmetics2 observations

E&H Distributors Llc · San Diego, United States · Issued September 12, 2017

Overview

  • 2 public-safe observations are available for this inspection.
  • 2 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.

12 Sep 2017
21 CFR 1.512(b)(1)(i)(A)

Definition very small importer

Cited by Ana M Pietsch

12 Sep 2017
21 CFR 1.512(b)(2)

Develop FSVP

Cited by Ana M Pietsch

Inspected site

EDE&H Distributors LlcSan Diego, United States

Inspection team

AMAna M Pietsch

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 1.512(b)(1)(i)(A)Cited across public-safe Form 483 observations1x
21 CFR 1.512(b)(2)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 2 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