FDA-Inspected Site

Regalabs

3 FDA inspections are on record for Regalabs in Canton, United States.

483· Form 483 issued

Canton, United States · Last updated July 11, 2026

Overview

  • 3 FDA inspections are on record.
  • 2 inspections produced a Form 483.
  • The most recent recorded inspection date is 2026-06-04.

At a glance

Inspections

3

Form 483s

2

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
27 May 2026 – 4 Jun 2026Foods & Cosmetics483View 483 →
25 Oct 2022 – 4 Nov 2022Foods & Cosmetics483View 483 →
12 Nov 2019Human DrugsClean

Observations on record

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

4 Jun 2026
21 CFR 111.120(e)

Quality control operations - quarantine

Cited by Joseph F Owens

4 Jun 2026
21 CFR 111.140(b)(1)

Quality control operations; written procedures; material review, disposition

Cited by Joseph F Owens

4 Jun 2026
21 CFR 111.260

Batch record - required information

Cited by Joseph F Owens

4 Jun 2026
21 CFR 111.27(b)

Instruments - calibration

Cited by Joseph F Owens

4 Jun 2026
21 CFR 111.75(a)(2)(ii)(A)

Component - qualify supplier

Cited by Joseph F Owens

Investigators

FDA investigators tied to this site in the record.

Dmitry Gazarian1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 111.120(e)Cited across public-safe Form 483 observations2x
21 CFR 111.140(b)(1)Cited across public-safe Form 483 observations2x
21 CFR 111.75(a)(2)(ii)(A)Cited across public-safe Form 483 observations2x
21 CFR 111.260Cited across public-safe Form 483 observations1x
21 CFR 111.27(b)Cited across public-safe Form 483 observations1x
21 CFR 111.370Cited across public-safe Form 483 observations1x
21 CFR 111.453Cited across public-safe Form 483 observations1x
21 CFR 111.475(b)(2)Cited across public-safe Form 483 observations1x
21 CFR 111.553Cited across public-safe Form 483 observations1x
21 CFR 111.83(a)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Regalabs' 2 Form 483s

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