Form 483

Universal Packaging Systems, Inc. Form 483, 2023-03-17

FDA issued a Form 483 to Universal Packaging Systems, Inc. on 2023-03-17 with 5 public-safe observations.

483· Form 483 issuedHuman Drugs5 observations

Universal Packaging Systems, Inc. · Chino, United States · Issued March 17, 2023

Overview

  • 5 public-safe observations are available for this inspection.
  • 5 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.

17 Mar 2023
21 CFR 211.100(a)

Absence of Written Procedures

Cited by Matthew R Clabeaux

17 Mar 2023
21 CFR 211.56(a)

Sanitation--buildings not clean, free of infestation

Cited by Matthew R Clabeaux

17 Mar 2023
21 CFR 211.63

Equipment Design, Size and Location

Cited by Matthew R Clabeaux

17 Mar 2023
21 CFR 211.68(a)

Calibration/Inspection/Checking not done

Cited by Matthew R Clabeaux

17 Mar 2023
21 CFR 211.84(d)(2)

Component identification test

Cited by Matthew R Clabeaux

Inspected site

UPUniversal Packaging Systems, Inc.Chino, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.100(a)Cited across public-safe Form 483 observations1x
21 CFR 211.56(a)Cited across public-safe Form 483 observations1x
21 CFR 211.63Cited across public-safe Form 483 observations1x
21 CFR 211.68(a)Cited across public-safe Form 483 observations1x
21 CFR 211.84(d)(2)Cited across public-safe Form 483 observations1x

Source document

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Form 483 source document

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Full 483 report

Get the verbatim text of all 5 observations

The source PDF, 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