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Form 483

M.d. Science Lab, L.l.c. Form 483, 2026-02-10

FDA issued a Form 483 to M.d. Science Lab, L.l.c. on 2026-02-10 with 8 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health8 observations

M.d. Science Lab, L.l.c. · Deerfield Beach, United States · Issued February 10, 2026

Overview

  • 8 public-safe observations are available for this inspection.
  • 8 structured CFR citations are represented.
  • 2 investigators are tied to this Form 483.

Inspectional observations

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

10 Feb 2026
21 CFR 801.20(a)

Label to bear a unique device identifier

Cited by Ebony D Sanon, Lorraine N Williams

10 Feb 2026
21 CFR 830.300(a)

Devices subject to device identification GUDID data submission requirements.

Cited by Ebony D Sanon, Lorraine N Williams

10 Feb 2026
ISO 13485:2016 Clause 4.1.2

Risk-based approach not applied to QMS processes

Cited by Ebony D Sanon, Lorraine N Williams

10 Feb 2026
ISO 13485:2016 Clause 4.2.3

Medical device file not established and maintained

Cited by Ebony D Sanon, Lorraine N Williams

10 Feb 2026
ISO 13485:2016 Clause 5.6.3

Management review output records lack input reviewed, decisions, and actions

Cited by Ebony D Sanon, Lorraine N Williams

Inspected site

MSM.d. Science Lab, L.l.c.Deerfield Beach, United States

Inspection team

EDEbony D Sanon
LNLorraine N Williams

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 801.20(a)Cited across public-safe Form 483 observations1x
21 CFR 830.300(a)Cited across public-safe Form 483 observations1x
ISO 13485:2016 Clause 4.1.2Cited across public-safe Form 483 observations1x
ISO 13485:2016 Clause 4.2.3Cited across public-safe Form 483 observations1x
ISO 13485:2016 Clause 5.6.3Cited across public-safe Form 483 observations1x
ISO 13485:2016 Clause 7.5.11Cited across public-safe Form 483 observations1x
ISO 13485:2016 Clause 8.2.2Cited across public-safe Form 483 observations1x
ISO 13485:2016 Clause 8.2.4Cited 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 8 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