Atlas

Form 483

Intershell International Corp. Form 483, 2023-12-07

FDA issued a Form 483 to Intershell International Corp. on 2023-12-07 with 2 public-safe observations.

483· Form 483 issuedFoods & Cosmetics2 observations

Intershell International Corp. · Gloucester, United States · Issued December 7, 2023

Overview

  • 2 public-safe observations are available for this inspection.
  • 2 structured CFR citations are represented.
  • 2 investigators are tied to this Form 483.

Inspectional observations

Each observation cites the regulation FDA found the firm out of compliance with.

7 Dec 2023
21 CFR 123.6(b)

HACCP plan implementation

Cited by Osama A Khatib, Douglas S Joslin

7 Dec 2023
21 CFR 123.6(c)(3)

Critical limits

Cited by Osama A Khatib, Douglas S Joslin

Inspected site

IIIntershell International Corp.Gloucester, United States

Inspection team

OAOsama A Khatib
DSDouglas S Joslin

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 123.6(b)Cited across public-safe Form 483 observations1x
21 CFR 123.6(c)(3)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 2 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