Form 483

MICROspecialties, LLC Form 483, 2025-02-18

FDA issued a Form 483 to MICROspecialties, LLC on 2025-02-18 with 5 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health5 observations

MICROspecialties, LLC · Middletown, United States · Issued February 18, 2025

Overview

  • 5 public-safe observations are available for this inspection.
  • 5 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.

18 Feb 2025
21 CFR 820.100(b)

Documentation

Cited by Eric C Schmitt

18 Feb 2025
21 CFR 820.181

DMR - not or inadequately maintained

Cited by Eric C Schmitt

18 Feb 2025
21 CFR 820.75(a)

Lack of or inadequate process validation

Cited by Eric C Schmitt

18 Feb 2025
21 CFR 820.80(d)

Lack of or inadequate final acceptance procedures

Cited by Eric C Schmitt

18 Feb 2025
21 CFR 820.90(a)

Nonconforming product control

Cited by Eric C Schmitt

Inspected site

MLMICROspecialties, LLCMiddletown, United States

Inspection team

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 820.100(b)Cited across public-safe Form 483 observations1x
21 CFR 820.181Cited across public-safe Form 483 observations1x
21 CFR 820.75(a)Cited across public-safe Form 483 observations1x
21 CFR 820.80(d)Cited across public-safe Form 483 observations1x
21 CFR 820.90(a)Cited across public-safe Form 483 observations1x

Source document

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PDF available

Form 483 source document

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Full 483 report

Get the verbatim text of all 5 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