Atlas

FDA-Inspected Site

Cetylite Industries, Inc.

11 FDA inspections are on record for Cetylite Industries, Inc. in Pennsauken, United States.

483· Form 483 issued

Pennsauken, United States · Last updated July 10, 2026

Overview

  • 11 FDA inspections are on record.
  • 8 inspections produced a Form 483.
  • The most recent recorded inspection date is 2025-04-07.

At a glance

Inspections

11

Form 483s

8

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
25 Mar 2025 – 7 Apr 2025Medical Devices & Rad Health483View 483 →
14 Nov 2024 – 9 Dec 2024Human Drugs483View 483 →
13 Feb 2023 – 2 Mar 2023Human Drugs483View 483 →
20 Sep 2021 – 24 Sep 2021Human DrugsWLView 483 →
12 Dec 2019 – 20 Dec 2019Human Drugs483View 483 →
14 May 2018 – 29 May 2018Human Drugs483View 483 →
9 Nov 2015 – 19 Nov 2015Human Drugs483View 483 →
10 Jul 2013 – 12 Jul 2013Medical Devices & Rad HealthClean
26 Apr 2011Not recorded483View 483 →
14 Oct 2008Not recordedClean
14 Jun 2000Not recordedClean

Observations on record

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

7 Apr 2025
21 CFR 820.22

Quality audits - Lack of or inadequate procedures

Cited by Shirley S Wen

7 Apr 2025
21 CFR 820.22

Quality audits - Lack of or inadequate procedures

Cited by Shirley S Wen

7 Apr 2025
21 CFR 820.50

Purchasing controls, Lack of or inadequate procedures

Cited by Shirley S Wen

7 Apr 2025
21 CFR 820.50

Purchasing controls, Lack of or inadequate procedures

Cited by Shirley S Wen

9 Dec 2024
21 CFR 211.100(a)

Absence of Written Procedures

Cited by Juanita P Versace, Rahi D Patel

Investigators

FDA investigators tied to this site in the record.

Russell J Glapion4 insp.
Nancy M Espinal2 insp.
Paul L Bellamy2 insp.
Shirley S Wen1 insp.
Juanita P Versace1 insp.
Rahi D Patel1 insp.
James R Birkenstamm1 insp.
Ankur C Patel1 insp.
Syeda N Mahazabin1 insp.
Nina Yang1 insp.
Devon Jenkins1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 211.192Cited across public-safe Form 483 observations6x
21 CFR 211.160(b)Cited across public-safe Form 483 observations5x
21 CFR 211.165(f)Cited across public-safe Form 483 observations3x
21 CFR 211.22(d)Cited across public-safe Form 483 observations3x
21 CFR 211.25(c)Cited across public-safe Form 483 observations3x
21 CFR 211.137(a)Cited across public-safe Form 483 observations2x
21 CFR 211.80(d)Cited across public-safe Form 483 observations2x
21 CFR 310.305(a)Cited across public-safe Form 483 observations2x
21 CFR 310.305(c)(1)(i)Cited across public-safe Form 483 observations2x
21 CFR 820.22Cited across public-safe Form 483 observations2x
21 CFR 820.50Cited across public-safe Form 483 observations2x
21 CFR 211.100(a)Cited across public-safe Form 483 observations1x
21 CFR 211.110(a)Cited across public-safe Form 483 observations1x
21 CFR 211.113(a)Cited across public-safe Form 483 observations1x
21 CFR 211.115(a)Cited across public-safe Form 483 observations1x
21 CFR 211.160(a)Cited across public-safe Form 483 observations1x
21 CFR 211.165(b)Cited across public-safe Form 483 observations1x
21 CFR 211.166(a)(3)Cited across public-safe Form 483 observations1x
21 CFR 211.194(d)Cited across public-safe Form 483 observations1x
21 CFR 211.67(a)Cited across public-safe Form 483 observations1x
21 CFR 211.67(b)Cited across public-safe Form 483 observations1x
21 CFR 211.87Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Cetylite Industries, Inc.'s 8 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