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Form 483

Arcamed LLC Form 483, 2023-09-21

FDA issued a Form 483 to Arcamed LLC on 2023-09-21 with 3 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health3 observations

Arcamed LLC · Indianapolis, United States · Issued September 21, 2023

Overview

  • 3 public-safe observations are available for this inspection.
  • 3 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.

21 Sep 2023
21 CFR 820.100(a)

Lack of or inadequate procedures

Cited by Debara R Reese

21 Sep 2023
21 CFR 820.22

Quality audits - Lack of or inadequate procedures

Cited by Debara R Reese

21 Sep 2023
21 CFR 820.90(a)

Nonconforming product, Lack of or inadequate procedures

Cited by Debara R Reese

Inspected site

ALArcamed LLCIndianapolis, United States

Inspection team

DRDebara R Reese

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 820.100(a)Cited across public-safe Form 483 observations1x
21 CFR 820.22Cited across public-safe Form 483 observations1x
21 CFR 820.90(a)Cited across public-safe Form 483 observations1x

Source document

PDF
PDF available

Form 483 source document

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Full 483 report

Get the verbatim text of all 3 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