Form 483

New B.C.N. Trading Inc Form 483, 2024-08-06

FDA issued a Form 483 to New B.C.N. Trading Inc on 2024-08-06 with 4 public-safe observations.

483· Form 483 issuedFoods & Cosmetics4 observations

New B.C.N. Trading Inc · South Plainfield, United States · Issued August 6, 2024

Overview

  • 4 public-safe observations are available for this inspection.
  • 3 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.

6 Aug 2024
21 CFR 1.502(a)

Develop FSVP

Cited by Diane B Radice

6 Aug 2024
21 CFR 1.502(a)

FSVP assurances

Cited by Diane B Radice

6 Aug 2024
21 CFR 1.505(c)(1)

Revaluate - new information

Cited by Diane B Radice

6 Aug 2024
21 CFR 1.506(e)(1)

Verification activity before import, periodically

Cited by Diane B Radice

Inspected site

NBNew B.C.N. Trading IncSouth Plainfield, 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 observations2x
21 CFR 1.505(c)(1)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