Form 483

Lilly France Form 483, 2019-02-19

FDA issued a Form 483 to Lilly France on 2019-02-19 with 6 public-safe observations.

483· Form 483 issuedHuman Drugs6 observations

Lilly France · Fegersheim, France · Issued February 19, 2019

Overview

  • 6 public-safe observations are available for this inspection.
  • 3 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.

19 Feb 2019
21 CFR 211.194(c)

Testing and standardization of standards et. al.

Cited by Yasamin Ameri

19 Feb 2019
21 CFR 211.63

Equipment Design, Size and Location

Cited by Yasamin Ameri

19 Feb 2019
21 CFR 211.67(a)

Cleaning / Sanitizing / Maintenance

Cited by Yasamin Ameri

19 Feb 2019
21 CFR 211.194(c)

Testing and standardization of standards et. al.

Cited by Yasamin Ameri

19 Feb 2019
21 CFR 211.63

Equipment Design, Size and Location

Cited by Yasamin Ameri

Inspected site

LFLilly FranceFegersheim, France

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.194(c)Cited across public-safe Form 483 observations2x
21 CFR 211.63Cited across public-safe Form 483 observations2x
21 CFR 211.67(a)Cited across public-safe Form 483 observations2x

Full 483 report

Get the verbatim text of all 6 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