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Form 483

Leadiant Biosciences, Inc. Form 483, 2021-07-08

FDA issued a Form 483 to Leadiant Biosciences, Inc. on 2021-07-08 with 1 public-safe observation.

483· Form 483 issuedHuman Drugs1 observation

Leadiant Biosciences, Inc. · Gaithersburg, United States · Issued July 8, 2021

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.

8 Jul 2021
21 CFR 314.80(c)(2)

Interval

Cited by John Dan

Inspected site

LBLeadiant Biosciences, Inc.Gaithersburg, United States

Inspection team

JDJohn Dan

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 314.80(c)(2)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 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