Form 483

BPI Labs, LLC Form 483, 2025-02-21

FDA issued a Form 483 to BPI Labs, LLC on 2025-02-21 with 1 public-safe observation.

483· Form 483 issuedHuman Drugs1 observation

BPI Labs, LLC · Largo, United States · Issued February 21, 2025

Overview

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

Inspectional observations

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

21 Feb 2025
FDCA 503B(a)(10)(A)

Drug product labels, fails to include

Cited by Nicole E Knowlton, Logan T Williams

Inspected site

BLBPI Labs, LLCLargo, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
FDCA 503B(a)(10)(A)Cited across public-safe Form 483 observations1x

Source document

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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