Form 483

FIVE GOODS INC Form 483, 2023-12-22

FDA issued a Form 483 to FIVE GOODS INC on 2023-12-22 with 11 public-safe observations.

483· Form 483 issuedFoods & Cosmetics11 observations

FIVE GOODS INC · Long Island City, United States · Issued December 22, 2023

Overview

  • 11 public-safe observations are available for this inspection.
  • 11 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.

22 Dec 2023
21 CFR 1.502(a)

Develop FSVP

Cited by David I Cho

22 Dec 2023
21 CFR 1.504(a)

Hazard analysis written

Cited by David I Cho

22 Dec 2023
21 CFR 1.504(b)(1)

Hazard analysis biological, chemical, physical

Cited by David I Cho

22 Dec 2023
21 CFR 1.504(d)

Document review entity's hazard analysis

Cited by David I Cho

22 Dec 2023
21 CFR 1.505(a)(2)

Evaluation - performance, risk

Cited by David I Cho

Inspected site

FGFIVE GOODS INCLong Island City, 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 1.504(a)Cited across public-safe Form 483 observations1x
21 CFR 1.504(b)(1)Cited across public-safe Form 483 observations1x
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(b)Cited across public-safe Form 483 observations1x
21 CFR 1.506(a)(1)Cited across public-safe Form 483 observations1x
21 CFR 1.506(b)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
21 CFR 1.510(b)(1)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 11 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