Atlas

Form 483

Element Materials Technology Pharma US LLC Form 483, 2019-05-03

FDA issued a Form 483 to Element Materials Technology Pharma US LLC on 2019-05-03 with 4 public-safe observations.

483· Form 483 issuedHuman Drugs4 observations

Element Materials Technology Pharma US LLC · Santa Fe Springs, United States · Issued May 3, 2019

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.

3 May 2019
21 CFR 211.160(a)

Following/documenting laboratory controls

Cited by Liming Zhang

3 May 2019
21 CFR 211.160(a)

Following/documenting laboratory controls

Cited by Liming Zhang

3 May 2019
21 CFR 211.25(a)

Training--operations, GMPs, written procedures

Cited by Liming Zhang

3 May 2019
21 CFR 211.25(a)

Training--operations, GMPs, written procedures

Cited by Liming Zhang

Inspected site

EMElement Materials Technology Pharma US LLCSanta Fe Springs, United States

Inspection team

LZLiming Zhang

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.160(a)Cited across public-safe Form 483 observations2x
21 CFR 211.25(a)Cited across public-safe Form 483 observations2x

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