Atlas

Form 483

Ellis Family Holdings, LLC Form 483, 2010-12-06

FDA issued a Form 483 to Ellis Family Holdings, LLC on 2010-12-06 with 4 public-safe observations.

483· Form 483 issued4 observations

Ellis Family Holdings, LLC · Florence, United States · Issued December 6, 2010

Overview

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

6 Dec 2010
21 CFR 211.94(a)

Reactive/Additive/Absorptive Containers/Closures

Cited by Nadeem I Chaudhry

6 Dec 2010
21 CFR 211.137(a)

Expiration date lacking

Cited by Nadeem I Chaudhry

6 Dec 2010
21 CFR 211.166(a)

Lack of written stability program

Cited by Nadeem I Chaudhry

6 Dec 2010
21 CFR 211.170(b)

Drug product reserve containers

Cited by Nadeem I Chaudhry

Inspected site

EFEllis Family Holdings, LLCFlorence, United States

Inspection team

NINadeem I Chaudhry

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.137(a)Cited across public-safe Form 483 observations1x
21 CFR 211.166(a)Cited across public-safe Form 483 observations1x
21 CFR 211.170(b)Cited across public-safe Form 483 observations1x
21 CFR 211.94(a)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 4 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