Form 483

Circle Net International Inc Form 483, 2022-11-23

FDA issued a Form 483 to Circle Net International Inc on 2022-11-23 with 4 public-safe observations.

483· Form 483 issuedFoods & Cosmetics4 observations

Circle Net International Inc · Pleasanton, United States · Issued November 23, 2022

Overview

  • 4 public-safe observations are available for this inspection.
  • 4 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.

23 Nov 2022
21 CFR 1.504(d)

Document review entity's hazard analysis

Cited by James S Lo

23 Nov 2022
21 CFR 1.505(a)(2)

Evaluation - performance, risk

Cited by James S Lo

23 Nov 2022
21 CFR 1.505(c)(2)

Reevaluate - 3 years

Cited by James S Lo

23 Nov 2022
21 CFR 1.506(b)

Supplier verification - establish written procedures

Cited by James S Lo

Inspected site

CNCircle Net International IncPleasanton, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 1.504(d)Cited across public-safe Form 483 observations1x
21 CFR 1.505(a)(2)Cited across public-safe Form 483 observations1x
21 CFR 1.505(c)(2)Cited across public-safe Form 483 observations1x
21 CFR 1.506(b)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 4 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