Atlas

FDA-Inspected Site

Carlsbad Technology, Inc.

16 FDA inspections are on record for Carlsbad Technology, Inc. in Carlsbad, United States.

483· Form 483 issued

Carlsbad, United States · Last updated July 10, 2026

Overview

  • 16 FDA inspections are on record.
  • 7 inspections produced a Form 483.
  • The most recent recorded inspection date is 2021-11-05.

At a glance

Inspections

16

Form 483s

7

EIRs

3

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
28 Oct 2021 – 5 Nov 2021Human Drugs483View 483 →
1 Aug 2019 – 9 Aug 2019Human DrugsClean
31 Oct 2016 – 4 Nov 2016Human Drugs483View 483 →
21 Oct 2014 – 21 Nov 2014Human Drugs483On file
17 Nov 2011Not recorded483View 483 →
26 May 2011Not recorded483View 483 →
12 Mar 2010Not recorded483On file
24 Apr 2009Not recorded483View 483 →
30 Sep 2008Not recordedClean
10 Jan 2008Not recordedClean
17 Jan 2006Not recordedClean
30 Mar 2005Not recordedClean

Observations on record

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

5 Nov 2021
21 CFR 211.100(b)

SOPs not followed / documented

Cited by Saied A Asbagh

4 Nov 2016
21 CFR 211.113(a)

Procedures for non-sterile drug products

Cited by William J Leonard

4 Nov 2016
21 CFR 211.160(a)

Following/documenting laboratory controls

Cited by William J Leonard

4 Nov 2016
21 CFR 211.22(d)

Procedures not in writing, fully followed

Cited by William J Leonard

4 Nov 2016
21 CFR 211.84(d)(2)

Testing Each Component for Conformity with Specs

Cited by William J Leonard

Investigators

FDA investigators tied to this site in the record.

Virgilio F Pacio2 insp.
Linda Thai2 insp.
Saied A Asbagh1 insp.
Sandra S Saniga1 insp.
William J Leonard1 insp.
Arie Menachem1 insp.
Diane C Van Leeuwen1 insp.
Binh T Nguyen1 insp.
Thomas R Beilke1 insp.
Joey V Quitania1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 211.100(b)Cited across public-safe Form 483 observations2x
21 CFR 211.110(a)Cited across public-safe Form 483 observations2x
21 CFR 211.160(b)Cited across public-safe Form 483 observations2x
21 CFR 211.192Cited across public-safe Form 483 observations2x
21 CFR 211.63Cited across public-safe Form 483 observations2x
21 CFR 211.84(d)(2)Cited across public-safe Form 483 observations2x
21 CFR 211.100(a)Cited across public-safe Form 483 observations1x
21 CFR 211.111Cited across public-safe Form 483 observations1x
21 CFR 211.113(a)Cited across public-safe Form 483 observations1x
21 CFR 211.137(b)Cited across public-safe Form 483 observations1x
21 CFR 211.160(a)Cited across public-safe Form 483 observations1x
21 CFR 211.160(b)(3)Cited across public-safe Form 483 observations1x
21 CFR 211.165(a)Cited across public-safe Form 483 observations1x
21 CFR 211.166(a)Cited across public-safe Form 483 observations1x
21 CFR 211.188(b)(8)Cited across public-safe Form 483 observations1x
21 CFR 211.194(a)Cited across public-safe Form 483 observations1x
21 CFR 211.194(a)(8)Cited across public-safe Form 483 observations1x
21 CFR 211.22(d)Cited across public-safe Form 483 observations1x
21 CFR 211.68(a)Cited across public-safe Form 483 observations1x
21 CFR 211.80(a)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Carlsbad Technology, Inc.'s 7 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