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Form 483

Unipharm Inc. Form 483, 2021-10-28

FDA issued a Form 483 to Unipharm Inc. on 2021-10-28 with 2 public-safe observations.

483· Form 483 issuedFoods & Cosmetics2 observations

Unipharm Inc. · Waterbury, United States · Issued October 28, 2021

Overview

  • 2 public-safe observations are available for this inspection.
  • 1 structured CFR citation is represented.
  • 1 investigator is tied to this Form 483.

Inspectional observations

Each observation cites the regulation FDA found the firm out of compliance with.

28 Oct 2021
21 CFR 111.10(b)(5)

Gloves

Cited by Emily J Schramm

28 Oct 2021
21 CFR 111.10(b)(5)

Gloves

Cited by Emily J Schramm

Inspected site

UIUnipharm Inc.Waterbury, United States

Inspection team

EJEmily J Schramm

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 111.10(b)(5)Cited across public-safe Form 483 observations2x

Full 483 report

Get the verbatim text of all 2 observations

The full inspection record, as Atlas holds it, so your team sees exactly what was cited and how it was answered.

  • The site's full inspection history around this Form 483
  • Whether these citations escalated to a warning letter
  • The investigators involved and the citations they repeat elsewhere