Form 483

MODERN MEDICAL SUPPLIES LLC Form 483, 2024-07-10

FDA issued a Form 483 to MODERN MEDICAL SUPPLIES LLC on 2024-07-10 with 4 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health4 observations

MODERN MEDICAL SUPPLIES LLC · Henderson, United States · Issued July 10, 2024

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.

10 Jul 2024
21 CFR 803.17

Lack of Written MDR Procedures

Cited by Christine I Shaw

10 Jul 2024
21 CFR 820.100(a)

Lack of or inadequate procedures

Cited by Christine I Shaw

10 Jul 2024
21 CFR 820.150

Lack of or inadequate procedures for storage.

Cited by Christine I Shaw

10 Jul 2024
21 CFR 820.198(a)

Lack of or inadequate complaint procedures

Cited by Christine I Shaw

Inspected site

MMMODERN MEDICAL SUPPLIES LLCHenderson, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 803.17Cited across public-safe Form 483 observations1x
21 CFR 820.100(a)Cited across public-safe Form 483 observations1x
21 CFR 820.150Cited across public-safe Form 483 observations1x
21 CFR 820.198(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 4 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