Atlas

FDA-Inspected Site

LEC Custom Products, Inc

3 FDA inspections are on record for LEC Custom Products, Inc in Mississauga, Canada.

Clean· No action indicated

Mississauga, Canada · Last updated August 15, 2026

Overview

  • 3 FDA inspections are on record.
  • 2 inspections produced a Form 483.
  • The most recent recorded inspection date is 2026-05-01.

At a glance

Inspections

3

Form 483s

2

EIRs

0

Last outcome

Clean

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
27 Apr 2026 – 1 May 2026Human DrugsClean
29 Aug 2022 – 2 Sep 2022Human Drugs483View 483 →
9 Sep 2019 – 12 Sep 2019Human Drugs483View 483 →

Observations on record

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

2 Sep 2022
21 CFR 211.105(b)

Distinctive ID or code not recorded in batch record

Cited by Camerson E Moore

2 Sep 2022
21 CFR 211.125(a)

Strict control not exercised over labeling issued

Cited by Camerson E Moore

2 Sep 2022
21 CFR 211.182

Written records kept in individual logs

Cited by Camerson E Moore

2 Sep 2022
21 CFR 211.186(b)(9)

Manufacturing Instructions and Specifications

Cited by Camerson E Moore

2 Sep 2022
21 CFR 211.22(d)

Procedures not in writing, fully followed

Cited by Camerson E Moore

Investigators

FDA investigators tied to this site in the record.

Vaishali J Patel1 insp.
Camerson E Moore1 insp.
Lauren N Howard1 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 observations2x
21 CFR 211.105(a)Cited across public-safe Form 483 observations1x
21 CFR 211.105(b)Cited across public-safe Form 483 observations1x
21 CFR 211.110(a)Cited across public-safe Form 483 observations1x
21 CFR 211.125(a)Cited across public-safe Form 483 observations1x
21 CFR 211.165(a)Cited across public-safe Form 483 observations1x
21 CFR 211.182Cited across public-safe Form 483 observations1x
21 CFR 211.186(b)(9)Cited across public-safe Form 483 observations1x
21 CFR 211.188Cited across public-safe Form 483 observations1x
21 CFR 211.192Cited across public-safe Form 483 observations1x
21 CFR 211.63Cited across public-safe Form 483 observations1x
21 CFR 211.67(a)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind LEC Custom Products, Inc's 2 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