Form 483

Eurofins EAG Materials Science, LLC Form 483, 2010-08-23

FDA issued a Form 483 to Eurofins EAG Materials Science, LLC on 2010-08-23 with 3 public-safe observations.

483· Form 483 issued3 observations

Eurofins EAG Materials Science, LLC · Maryland Heights, United States · Issued August 23, 2010

Overview

  • 3 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.

23 Aug 2010
21 CFR 211.100(b)

SOPs not followed / documented

Cited by Michele Perry Williams

23 Aug 2010
21 CFR 211.198(a)

Complaint Handling Procedure

Cited by Michele Perry Williams

23 Aug 2010
21 CFR 211.198(b)(1)

Complaint Record required information

Cited by Michele Perry Williams

Inspected site

EEEurofins EAG Materials Science, LLCMaryland Heights, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.100(b)Cited across public-safe Form 483 observations1x
21 CFR 211.198(a)Cited across public-safe Form 483 observations1x
21 CFR 211.198(b)(1)Cited across public-safe Form 483 observations1x

Source document

PDF
PDF available

Form 483 source document

The source document is available to authorized Atlas users.

Full 483 report

Get the verbatim text of all 3 observations

The source PDF and 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