FDA-Inspected Site

Unipharm Inc.

3 FDA inspections are on record for Unipharm Inc. in Waterbury, United States.

483· Form 483 issued

Waterbury, United States · Last updated August 15, 2026

Overview

  • 3 FDA inspections are on record.
  • 3 inspections produced a Form 483.
  • The most recent recorded inspection date is 2025-11-21.

At a glance

Inspections

3

Form 483s

3

EIRs

0

Last outcome

Form 483

Inspection history

FDA inspections on record, most recent first.

InspectionCategoryOutcomeForm 483
18 Nov 2025 – 21 Nov 2025Human Drugs483View 483 →
26 Sep 2022 – 5 Oct 2022Human Drugs483View 483 →
26 Oct 2021 – 28 Oct 2021Foods & Cosmetics483View 483 →

Observations on record

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

21 Nov 2025
21 CFR 211.100(a)

Absence of Written Procedures

Cited by Alisha B Patel

21 Nov 2025
21 CFR 211.103

Actual vs. theoretical yields not determined

Cited by Alisha B Patel

21 Nov 2025
21 CFR 211.22(d)

Procedures not in writing, fully followed

Cited by Alisha B Patel

21 Nov 2025
21 CFR 211.63

Equipment Design, Size and Location

Cited by Alisha B Patel

5 Oct 2022
21 CFR 211.110(a)

Control procedures to monitor and validate performance

Cited by Jonah S Ufferfilge, Samir C Gala

Investigators

FDA investigators tied to this site in the record.

Recurring citations

CFR citation patterns observed across this site's inspections.

CitationWhat it coversCited
21 CFR 111.10(b)(5)Cited across public-safe Form 483 observations2x
21 CFR 211.22(d)Cited across public-safe Form 483 observations2x
21 CFR 211.63Cited across public-safe Form 483 observations2x
21 CFR 211.100(a)Cited across public-safe Form 483 observations1x
21 CFR 211.103Cited across public-safe Form 483 observations1x
21 CFR 211.110(a)Cited 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 Unipharm Inc.'s 3 Form 483s

Source PDFs 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