Atlas

Form 483

Ellis Family Holdings, LLC Form 483, 2017-08-15

FDA issued a Form 483 to Ellis Family Holdings, LLC on 2017-08-15 with 2 public-safe observations.

483· Form 483 issuedHuman Drugs2 observations

Ellis Family Holdings, LLC · Florence, United States · Issued August 15, 2017

Overview

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

Inspectional observations

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

15 Aug 2017
21 CFR 211.122(d)

Labels and labeling stored separately

Cited by Heather A Mccauley, Kenneth E Felkley

15 Aug 2017
21 CFR 211.188(a)

Accurate reproduction

Cited by Heather A Mccauley, Kenneth E Felkley

Inspected site

EFEllis Family Holdings, LLCFlorence, United States

Inspection team

HAHeather A Mccauley
KEKenneth E Felkley

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.122(d)Cited across public-safe Form 483 observations1x
21 CFR 211.188(a)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