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Form 483

Element Materials Technology Oakland-Concord Form 483, 2018-12-21

FDA issued a Form 483 to Element Materials Technology Oakland-Concord on 2018-12-21 with 3 public-safe observations.

483· Form 483 issuedHuman Drugs3 observations

Element Materials Technology Oakland-Concord · Concord, United States · Issued December 21, 2018

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.

21 Dec 2018
21 CFR 211.160(b)(4)

Calibration - at intervals, written program, remedial action

Cited by Kristin M Abaonza

21 Dec 2018
21 CFR 211.22(d)

Procedures not in writing, fully followed

Cited by Kristin M Abaonza

21 Dec 2018
21 CFR 211.25(a)

Training--operations, GMPs, written procedures

Cited by Kristin M Abaonza

Inspected site

EMElement Materials Technology Oakland-ConcordConcord, United States

Inspection team

KMKristin M Abaonza

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.160(b)(4)Cited across public-safe Form 483 observations1x
21 CFR 211.22(d)Cited across public-safe Form 483 observations1x
21 CFR 211.25(a)Cited across public-safe Form 483 observations1x

Source document

PDF
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Form 483 source document

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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