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Form 483

Micro Distributing I I, Ltd Form 483, 2023-03-07

FDA issued a Form 483 to Micro Distributing I I, Ltd on 2023-03-07 with 4 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health4 observations

Micro Distributing I I, Ltd · Belton, United States · Issued March 7, 2023

Overview

  • 4 public-safe observations are available for this inspection.
  • 2 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.

7 Mar 2023
21 CFR 803.17

Lack of Written MDR Procedures

Cited by Katlin N Stubbs

7 Mar 2023
21 CFR 803.17

Lack of Written MDR Procedures

Cited by Katlin N Stubbs

7 Mar 2023
21 CFR 820.198(a)

Lack of or inadequate complaint procedures

Cited by Katlin N Stubbs

7 Mar 2023
21 CFR 820.198(a)

Lack of or inadequate complaint procedures

Cited by Katlin N Stubbs

Inspected site

MDMicro Distributing I I, LtdBelton, United States

Inspection team

KNKatlin N Stubbs

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 803.17Cited across public-safe Form 483 observations2x
21 CFR 820.198(a)Cited across public-safe Form 483 observations2x

Source document

PDF
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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