Form 483

Prolacta Bioscience Inc Form 483, 2015-10-20

FDA issued a Form 483 to Prolacta Bioscience Inc on 2015-10-20 with 3 public-safe observations.

483· Form 483 issuedFoods & Cosmetics3 observations

Prolacta Bioscience Inc · City Of Industry, United States · Issued October 20, 2015

Overview

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

Inspectional observations

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

20 Oct 2015
21 CFR 107.50(e)(2)

Notification - adulterated

Cited by Carla J Lundi, James A Barreto

20 Oct 2015
21 CFR 107.50(e)(2)

Notification - adulterated

Cited by Carla J Lundi, James A Barreto

20 Oct 2015
21 CFR 107.50(e)(2)

Notify FDA district - adulterated exempt, infant formula

Cited by Carla J Lundi, James A Barreto

Inspected site

PBProlacta Bioscience IncCity Of Industry, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 107.50(e)(2)Cited across public-safe Form 483 observations3x

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