Atlas

Form 483

Element Materials Technology Boston - Acton Inc. Form 483, 2011-11-10

FDA issued a Form 483 to Element Materials Technology Boston - Acton Inc. on 2011-11-10 with 1 public-safe observation.

483· Form 483 issued1 observation

Element Materials Technology Boston - Acton Inc. · Acton, United States · Issued November 10, 2011

Overview

  • 1 public-safe observation is available for this inspection.
  • 1 structured CFR citation is represented.
  • 2 investigators are tied to this Form 483.

Inspectional observations

Each observation cites the regulation FDA found the firm out of compliance with.

10 Nov 2011
21 CFR 211.165(e)

Test methods

Cited by Ramon E Martinez, Matthew D Silverman

Inspected site

EMElement Materials Technology Boston - Acton Inc.Acton, United States

Inspection team

RERamon E Martinez
MDMatthew D Silverman

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.165(e)Cited across public-safe Form 483 observations1x

Full 483 report

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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