Atlas

Form 483

Clear Guide Medical, Inc. Form 483, 2019-11-13

FDA issued a Form 483 to Clear Guide Medical, Inc. on 2019-11-13 with 16 public-safe observations.

483· Form 483 issuedMedical Devices & Rad Health16 observations

Clear Guide Medical, Inc. · Baltimore, United States · Issued November 13, 2019

Overview

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

13 Nov 2019
21 CFR 820.22

Quality audits - Lack of or inadequate procedures

Cited by Jude C Dike

13 Nov 2019
21 CFR 820.22

Quality audits - Lack of or inadequate procedures

Cited by Jude C Dike

13 Nov 2019
21 CFR 820.30(e)

Design review - Lack of or inadequate procedures

Cited by Jude C Dike

13 Nov 2019
21 CFR 820.30(e)

Design review - Lack of or inadequate procedures

Cited by Jude C Dike

13 Nov 2019
21 CFR 820.50

Purchasing controls, Lack of or inadequate procedures

Cited by Jude C Dike

Inspected site

CGClear Guide Medical, Inc.Baltimore, United States

Inspection team

JCJude C Dike

Cited regulations

CFR citations associated with this Form 483.

CitationWhat it coversCited
21 CFR 820.22Cited across public-safe Form 483 observations4x
21 CFR 820.30(e)Cited across public-safe Form 483 observations4x
21 CFR 820.50Cited across public-safe Form 483 observations4x
21 CFR 820.70(i)Cited across public-safe Form 483 observations4x

Full 483 report

Get the verbatim text of all 16 observations

The full inspection record, as Atlas holds it, 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