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Form 483

Unither Manufacturing LLC. Form 483, 2017-03-01

FDA issued a Form 483 to Unither Manufacturing LLC. on 2017-03-01 with 2 public-safe observations.

483· Form 483 issuedHuman Drugs2 observations

Unither Manufacturing LLC. · Rochester, United States · Issued March 1, 2017

Overview

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

Inspectional observations

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

1 Mar 2017
21 CFR 211.28(a)

Protective Apparel Not Worn

Cited by Parul M Patel

1 Mar 2017
21 CFR 211.67(a)

Cleaning / Sanitizing / Maintenance

Cited by Parul M Patel

Inspected site

UMUnither Manufacturing LLC.Rochester, United States

Inspection team

PMParul M Patel

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.28(a)Cited across public-safe Form 483 observations1x
21 CFR 211.67(a)Cited across public-safe Form 483 observations1x

Source document

PDF
PDF available

Form 483 source document

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Full 483 report

Get the verbatim text of all 2 observations

The source PDF and every observation in full, 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