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Form 483

Brands International Corporation Form 483, 2023-10-27

FDA issued a Form 483 to Brands International Corporation on 2023-10-27 with 1 public-safe observation.

483· Form 483 issuedHuman Drugs1 observation

Brands International Corporation · Newmarket, Canada · Issued October 27, 2023

Overview

  • 1 public-safe observation is available for this inspection.
  • 1 structured CFR citation is represented.
  • 1 investigator is tied to this Form 483.

Inspectional observations

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

27 Oct 2023
21 CFR 211.160(b)

Scientifically sound laboratory controls

Cited by Harshal J Desai

Inspected site

BIBrands International CorporationNewmarket, Canada

Inspection team

HJHarshal J Desai

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.160(b)Cited across public-safe Form 483 observations1x

Source document

PDF
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Form 483 source document

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Full 483 report

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The source PDF, 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