Form 483

Big Green (USA) Inc. Form 483, 2023-06-15

FDA issued a Form 483 to Big Green (USA) Inc. on 2023-06-15 with 4 public-safe observations.

483· Form 483 issuedFoods & Cosmetics4 observations

Big Green (USA) Inc. · City Of Industry, United States · Issued June 15, 2023

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.

15 Jun 2023
21 CFR 1.502(a)

Develop FSVP

Cited by Sorana Black

15 Jun 2023
21 CFR 1.505(a)(2)

Evaluation - performance, risk

Cited by Sorana Black

15 Jun 2023
21 CFR 1.506(d)(1)(i)

Verification activity assurance

Cited by Sorana Black

15 Jun 2023
21 CFR 1.506(e)(1)

Verification activity before import, periodically

Cited by Sorana Black

Inspected site

BGBig Green (USA) Inc.City Of Industry, 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 1.505(a)(2)Cited across public-safe Form 483 observations1x
21 CFR 1.506(d)(1)(i)Cited across public-safe Form 483 observations1x
21 CFR 1.506(e)(1)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