Atlas

FDA-Inspected Site

Element Materials Technology Oakland-Concord

5 FDA inspections are on record for Element Materials Technology Oakland-Concord in Concord, United States.

483· Form 483 issued

Concord, United States · Last updated July 10, 2026

Overview

  • 5 FDA inspections are on record.
  • 4 inspections produced a Form 483.
  • The most recent recorded inspection date is 2026-01-30.

At a glance

Inspections

5

Form 483s

4

EIRs

1

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
21 Jan 2026 – 30 Jan 2026Human Drugs483View 483 →
14 Mar 2022 – 22 Mar 2022Human Drugs483View 483 →
17 Dec 2018 – 21 Dec 2018Human Drugs483View 483 →
1 Jul 2014 – 8 Jul 2014Human Drugs483View 483 →
16 Jun 2009Not recordedClean

Observations on record

Form 483 observations cited at this site, most recent first.

30 Jan 2026
21 CFR 211.160(a)

Following/documenting laboratory controls

Cited by Roger F Zabinski, Jolanna A Norton, Homero W Aguilar, Anney Lin

30 Jan 2026
21 CFR 211.192

Written record of investigation incomplete

Cited by Roger F Zabinski, Jolanna A Norton, Homero W Aguilar, Anney Lin

30 Jan 2026
21 CFR 211.194(a)(5)

Calculations performed are in the records

Cited by Roger F Zabinski, Jolanna A Norton, Homero W Aguilar, Anney Lin

30 Jan 2026
21 CFR 211.22(d)

Procedures not in writing, fully followed

Cited by Roger F Zabinski, Jolanna A Norton, Homero W Aguilar, Anney Lin

30 Jan 2026
21 CFR 211.42(c)(10)(vi)

Equipment to control conditions

Cited by Roger F Zabinski, Jolanna A Norton, Homero W Aguilar, Anney Lin

Investigators

FDA investigators tied to this site in the record.

Jolanna A Norton2 insp.
Roger F Zabinski1 insp.
Homero W Aguilar1 insp.
Anney Lin1 insp.
Jeffrey P Raimondi1 insp.
Thomas J Arista1 insp.
Kristin M Abaonza1 insp.
Anh Lac1 insp.
Maida Henesian1 insp.
Eileen A Liu1 insp.
Jeffrey M Watson1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 211.22(d)Cited across public-safe Form 483 observations3x
21 CFR 211.160(a)Cited across public-safe Form 483 observations2x
21 CFR 211.160(b)Cited across public-safe Form 483 observations2x
21 CFR 211.160(b)(4)Cited across public-safe Form 483 observations2x
21 CFR 211.192Cited across public-safe Form 483 observations2x
21 CFR 211.68(a)Cited across public-safe Form 483 observations2x
21 CFR 211.100(a)Cited across public-safe Form 483 observations1x
21 CFR 211.113(b)Cited across public-safe Form 483 observations1x
21 CFR 211.194(a)(5)Cited across public-safe Form 483 observations1x
21 CFR 211.25(a)Cited across public-safe Form 483 observations1x
21 CFR 211.42(c)Cited across public-safe Form 483 observations1x
21 CFR 211.42(c)(10)(iii)Cited across public-safe Form 483 observations1x
21 CFR 211.42(c)(10)(v)Cited across public-safe Form 483 observations1x
21 CFR 211.42(c)(10)(vi)Cited across public-safe Form 483 observations1x
21 CFR 211.46(a)Cited across public-safe Form 483 observations1x
21 CFR 211.46(b)Cited across public-safe Form 483 observations1x
21 CFR 211.48(b)Cited across public-safe Form 483 observations1x
21 CFR 211.58Cited across public-safe Form 483 observations1x
21 CFR 211.67(b)(5)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Element Materials Technology Oakland-Concord's 4 Form 483s

Source PDFs, verbatim observations, and recurring CFR citations, so your team knows what this site gets cited for.

  • The site's full inspection history, with every Form 483 and its outcome
  • Warning letters and recalls tied to the company behind it
  • Whether recurring CFR citations get closed out or repeat