Atlas

Form 483

Intershell International Corp. Form 483, 2017-12-01

FDA issued a Form 483 to Intershell International Corp. on 2017-12-01 with 4 public-safe observations.

483· Form 483 issuedFoods & Cosmetics4 observations

Intershell International Corp. · Gloucester, United States · Issued December 1, 2017

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.

1 Dec 2017
21 CFR 123.6(b)

HACCP plan implementation

Cited by Osama A Khatib

1 Dec 2017
21 CFR 123.6(c)(1)

Food safety hazards

Cited by Osama A Khatib

1 Dec 2017
21 CFR 123.6(c)(3)

Critical limits

Cited by Osama A Khatib

1 Dec 2017
21 CFR 123.6(c)(4)

Monitoring - adequacy

Cited by Osama A Khatib

Inspected site

IIIntershell International Corp.Gloucester, United States

Inspection team

OAOsama A Khatib

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)(1)Cited across public-safe Form 483 observations1x
21 CFR 123.6(c)(3)Cited across public-safe Form 483 observations1x
21 CFR 123.6(c)(4)Cited across public-safe Form 483 observations1x

Full 483 report

Get the verbatim text of all 4 observations

Every observation in full, 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