Form 483

Pro Numb Tattoo Numbing Spray LLC Form 483, 2025-11-06

FDA issued a Form 483 to Pro Numb Tattoo Numbing Spray LLC on 2025-11-06 with 9 public-safe observations.

483· Form 483 issuedHuman Drugs9 observations

Pro Numb Tattoo Numbing Spray LLC · Palm Bay, United States · Issued November 6, 2025

Overview

  • 9 public-safe observations are available for this inspection.
  • 9 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.

6 Nov 2025
21 CFR 211.100(a)

Changes to Procedures Not Reviewed, Approved

Cited by Mabany Lizardi

6 Nov 2025
21 CFR 211.142(b)

Storage under appropriate conditions

Cited by Mabany Lizardi

6 Nov 2025
21 CFR 211.165(a)

Testing and release for distribution

Cited by Mabany Lizardi

6 Nov 2025
21 CFR 211.166(a)

Lack of written stability program

Cited by Mabany Lizardi

6 Nov 2025
21 CFR 211.192

Quality control unit review of records

Cited by Mabany Lizardi

Inspected site

PNPro Numb Tattoo Numbing Spray LLCPalm Bay, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 211.100(a)Cited across public-safe Form 483 observations1x
21 CFR 211.142(b)Cited across public-safe Form 483 observations1x
21 CFR 211.165(a)Cited across public-safe Form 483 observations1x
21 CFR 211.166(a)Cited across public-safe Form 483 observations1x
21 CFR 211.192Cited across public-safe Form 483 observations1x
21 CFR 211.22(a)Cited across public-safe Form 483 observations1x
21 CFR 211.25(a)Cited across public-safe Form 483 observations1x
21 CFR 211.68(a)Cited across public-safe Form 483 observations1x
21 CFR 211.80(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

Get the verbatim text of all 9 observations

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