Atlas

Form 483

Element Materials Technology Ann Arbor, LLC Form 483, 2018-03-22

FDA issued a Form 483 to Element Materials Technology Ann Arbor, LLC on 2018-03-22 with 4 public-safe observations.

483· Form 483 issuedHuman Drugs4 observations

Element Materials Technology Ann Arbor, LLC · Ann Arbor, United States · Issued March 22, 2018

Overview

  • 4 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.

22 Mar 2018
21 CFR 211.22(b)

Adequate lab facilities not available

Cited by Emily J Orban

22 Mar 2018
21 CFR 211.22(d)

Procedures not in writing, fully followed

Cited by Emily J Orban

22 Mar 2018
21 CFR 211.22(b)

Adequate lab facilities not available

Cited by Emily J Orban

22 Mar 2018
21 CFR 211.22(d)

Procedures not in writing, fully followed

Cited by Emily J Orban

Inspected site

EMElement Materials Technology Ann Arbor, LLCAnn Arbor, United States

Inspection team

EJEmily J Orban

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.22(b)Cited across public-safe Form 483 observations2x
21 CFR 211.22(d)Cited across public-safe Form 483 observations2x

Full 483 report

Get the verbatim text of all 4 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