Form 483

PLZ Corp Form 483, 2025-03-07

FDA issued a Form 483 to PLZ Corp on 2025-03-07 with 3 public-safe observations.

483· Form 483 issuedHuman Drugs3 observations

PLZ Corp · Mississauga, Canada · Issued March 7, 2025

Overview

  • 3 public-safe observations are available for this inspection.
  • 3 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.

7 Mar 2025
21 CFR 211.165(e)

Test methods

Cited by Rose L Jean-Mary

7 Mar 2025
21 CFR 211.22(d)

Procedures not in writing, fully followed

Cited by Rose L Jean-Mary

7 Mar 2025
21 CFR 211.67(a)

Cleaning / Sanitizing / Maintenance

Cited by Rose L Jean-Mary

Inspected site

PCPLZ CorpMississauga, Canada

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.165(e)Cited across public-safe Form 483 observations1x
21 CFR 211.22(d)Cited across public-safe Form 483 observations1x
21 CFR 211.67(a)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 3 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