Form 483

HEARTLAND SOCIETY OF NORTHERN CA INC. Form 483, 2021-08-09

FDA issued a Form 483 to HEARTLAND SOCIETY OF NORTHERN CA INC. on 2021-08-09 with 6 public-safe observations.

483· Form 483 issuedFoods & Cosmetics6 observations

HEARTLAND SOCIETY OF NORTHERN CA INC. · San Jose, United States · Issued August 9, 2021

Overview

  • 6 public-safe observations are available for this inspection.
  • 6 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.

9 Aug 2021
21 CFR 1.502(a)

Develop FSVP

Cited by Jeanne A Young

9 Aug 2021
21 CFR 1.503(a)

Qualified individual FSVP activities

Cited by Jeanne A Young

9 Aug 2021
21 CFR 1.504(a)

Hazard analysis written

Cited by Jeanne A Young

9 Aug 2021
21 CFR 1.505(b)

Supplier approval - document

Cited by Jeanne A Young

9 Aug 2021
21 CFR 1.506(e)(3)

Verification activity review, assess

Cited by Jeanne A Young

Inspected site

HSHEARTLAND SOCIETY OF NORTHERN CA INC.San Jose, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 1.502(a)Cited across public-safe Form 483 observations1x
21 CFR 1.503(a)Cited across public-safe Form 483 observations1x
21 CFR 1.504(a)Cited across public-safe Form 483 observations1x
21 CFR 1.505(b)Cited across public-safe Form 483 observations1x
21 CFR 1.506(e)(3)Cited across public-safe Form 483 observations1x
21 CFR 1.510(a)(2)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 6 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