Form 483

PLZ Corp Form 483, 2011-08-10

FDA issued a Form 483 to PLZ Corp on 2011-08-10 with 3 public-safe observations.

483· Form 483 issued3 observations

PLZ Corp · Riverside, United States · Issued August 10, 2011

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.

10 Aug 2011
21 CFR 211.67(a)

Cleaning / Sanitizing / Maintenance

Cited by John A Gonzalez

10 Aug 2011
21 CFR 211.192

Written record of investigation incomplete

Cited by John A Gonzalez

10 Aug 2011
21 CFR 211.194(a)

Complete test data included in records

Cited by John A Gonzalez

Inspected site

PCPLZ CorpRiverside, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.192Cited across public-safe Form 483 observations1x
21 CFR 211.194(a)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

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