Clear Guide Medical, Inc
Form 483 issued November 13, 2019 · Baltimore, Maryland
- Inspection
- Nov 6 – Nov 13, 2019
- Investigator
- Jude C. Dike
- Observations
- 4
- Pages
- 6
- FEI number
- 3011396687
In short: On November 13, 2019, FDA issued a Form 483 with 4 observations to Clear Guide Medical, Inc in Baltimore, Maryland (FEI 3011396687) after an inspection that ran Nov 6 – Nov 13, 2019. The investigator was Jude C. Dike. Most observations concern production & process controls and design controls.
At a glance
Production & process controls and design controls account for 3 of 4 observations.
What FDA observed
Preview: the opening words of each observation- 01
Software used as part of the quality system has not been validated for its intended use…
- 02
Procedures to ensure that all purchased or otherwise received product and services conform to specified requirements…
- 03
Procedures for design review have…
- 04
Procedures for quality audits have…
This inspection in context
Jude C. Dike
9 documents · 2015–2022
Cites 820.100 (corrective and preventive action) more than any other section. Most of their documents are for sites in Maryland.
The firmClear Guide Medical, Inc history
The site's inspection history, in date order.
Similar 483sOther sites cited under 820.70(i)
See how FDA wrote the same problem up elsewhere.
Questions about this 483
What did FDA find at Clear Guide Medical, Inc?
FDA listed 4 observations on this Form 483, mostly about production & process controls, design controls and management controls. The opening words of each observation are shown on this page.
Who inspected Clear Guide Medical, Inc?
Jude C. Dike is named on this Form 483, for the inspection of Nov 6 – Nov 13, 2019. Each investigator has a profile showing what they cite most.
When was Clear Guide Medical, Inc inspected by FDA?
The inspection ran Nov 6 – Nov 13, 2019, and the Form 483 is dated November 13, 2019.
How do I get the full Form 483 for Clear Guide Medical, Inc?
Download the original PDF from FDA Intel for $99, with no subscription. Your first Form 483 or letter is on us. You also get an invoice PDF with the order.