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Form 483

Oscor Inc. Form 483, 2025-02-11

FDA issued a Form 483 to Oscor Inc. on 2025-02-11 with 2 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health2 observations

Oscor Inc. · Palm Harbor, United States · Issued February 11, 2025

Overview

  • 2 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.

11 Feb 2025
21 CFR 820.100(a)

Lack of or inadequate procedures

Cited by Suzanne M Healy

11 Feb 2025
21 CFR 820.198(a)

Lack of or inadequate complaint procedures

Cited by Suzanne M Healy

Inspected site

OIOscor Inc.Palm Harbor, United States

Inspection team

SMSuzanne M Healy

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 820.198(a)Cited across public-safe Form 483 observations1x

Source document

PDF
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Form 483 source document

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Full 483 report

Get the verbatim text of all 2 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