Atlas

FDA-Inspected Site

QualTech Laboratories, Inc.

13 FDA inspections are on record for QualTech Laboratories, Inc. in Ocean, United States.

483· Form 483 issued

Ocean, United States · Last updated July 10, 2026

Overview

  • 13 FDA inspections are on record.
  • 3 inspections produced a Form 483.
  • The most recent recorded inspection date is 2026-04-13.

At a glance

Inspections

13

Form 483s

3

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
7 Apr 2026 – 13 Apr 2026Human Drugs483View 483 →
12 Oct 2022 – 25 Oct 2022Human DrugsClean
9 Jan 2018 – 11 Jan 2018Animal Drugs & FeedsClean
11 May 2016 – 12 May 2016Human DrugsClean
13 Nov 2014 – 19 Nov 2014Human DrugsClean
12 Mar 2013 – 8 Apr 2013Human DrugsClean
19 Dec 2011Not recorded483View 483 →
15 Mar 2010Not recordedClean
24 Jul 2009Not recorded483On file
11 Feb 2009Not recordedClean
30 May 2008Not recordedClean
15 Dec 2003Not recordedClean

Observations on record

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

13 Apr 2026
21 CFR 211.194(a)(1)

Sample identification and other information

Cited by Frederick Razzaghi

19 Dec 2011
21 CFR 211.63

Equipment Design, Size and Location

Cited by Jose M Cayuela

19 Dec 2011
21 CFR 211.160(b)(4)

Calibration - at intervals, written program, remedial action

Cited by Jose M Cayuela

19 Dec 2011
21 CFR 211.192

Written record of investigation incomplete

Cited by Jose M Cayuela

Investigators

FDA investigators tied to this site in the record.

Frederick Razzaghi1 insp.
Ko U Min1 insp.
Nancy M Espinal1 insp.
Tamil Arasu1 insp.
Adetutu M Gidado1 insp.
Russell J Glapion1 insp.
Barbara J Wilimczyk-Macri1 insp.
Jose M Cayuela1 insp.
Addam S Reynolds1 insp.
Dawn L Wydner1 insp.
Karen E Dorazio1 insp.
Dorothy J Denes1 insp.
Daniel J Grabicki1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 211.160(b)(4)Cited across public-safe Form 483 observations1x
21 CFR 211.192Cited across public-safe Form 483 observations1x
21 CFR 211.194(a)(1)Cited across public-safe Form 483 observations1x
21 CFR 211.63Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind QualTech Laboratories, Inc.'s 3 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