Atlas

FDA-Inspected Site

Unette Corp

9 FDA inspections are on record for Unette Corp in Randolph, United States.

483· Form 483 issued

Randolph, United States · Last updated July 10, 2026

Overview

  • 9 FDA inspections are on record.
  • 3 inspections produced a Form 483.
  • The most recent recorded inspection date is 2025-09-11.

At a glance

Inspections

9

Form 483s

3

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
9 Sep 2025 – 11 Sep 2025Human Drugs483On file
21 Jun 2022 – 22 Jun 2022Human DrugsClean
28 Dec 2016Human DrugsClean
14 Jul 2014 – 16 Jul 2014Human DrugsClean
15 Feb 2012Not recorded483View 483 →
30 Dec 2009Not recorded483View 483 →
6 Jul 2007Not recordedClean
28 Dec 2005Not recordedClean
18 Jul 2003Not recordedClean

Observations on record

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

15 Feb 2012
21 CFR 211.22(d)

Procedures not in writing, fully followed

Cited by Michael R Klapal

15 Feb 2012
21 CFR 211.63

Equipment Design, Size and Location

Cited by Michael R Klapal

30 Dec 2009
21 CFR 211.22(a)

Lack of quality control unit

Cited by Michael R Klapal, Kazi Rafiquzzaman

30 Dec 2009
21 CFR 211.63

Equipment Design, Size and Location

Cited by Michael R Klapal, Kazi Rafiquzzaman

30 Dec 2009
21 CFR 211.67(b)

Written procedures fail to include

Cited by Michael R Klapal, Kazi Rafiquzzaman

Investigators

FDA investigators tied to this site in the record.

Michael R Klapal2 insp.
Michael O Idowu1 insp.
Michele Gottshall1 insp.
Melissa T Roy1 insp.
Nancy F Scheraga1 insp.
Helen Verdel1 insp.
Kazi Rafiquzzaman1 insp.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 211.63Cited across public-safe Form 483 observations2x
21 CFR 211.105(b)Cited across public-safe Form 483 observations1x
21 CFR 211.184(c)Cited across public-safe Form 483 observations1x
21 CFR 211.186(b)(9)Cited across public-safe Form 483 observations1x
21 CFR 211.192Cited across public-safe Form 483 observations1x
21 CFR 211.22(a)Cited across public-safe Form 483 observations1x
21 CFR 211.22(d)Cited across public-safe Form 483 observations1x
21 CFR 211.67(b)Cited across public-safe Form 483 observations1x

Full site report

Get the verbatim findings behind Unette Corp'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