Sandra A Hughes

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Investigation Details

Last Issued Date

August 31, 2018

Conversion Rate

% Conversion

No. of 483’s Issued

Warning Letters Issued

Countries Inspected

INDIA, India, Italy, USA

FDA Investigators having one site common

Charles R Cate , Marie A Fadden , Eileen A Liu , Shirley J Berryman , Matthew H Hunt , Jasjeet K Sekhon , Joel D Hustedt , Justin A Boyd , Tenzin Jangchup

Detailed Analysis

Approach:

Investigator Hughes adopts a systematic and methodical approach during inspections. She emphasizes on meticulous verification of sterilization processes, thorough investigation of device failures and stringent adherence to MDR procedures, with a keen eye on the level and adequacy of documentation.

Profile:

FDA investigator, Sandra A Hughes, is a meticulous auditor that often focuses on areas involving sterilization processes, device failure investigations, equipment nonconformance, and adherence to MDR procedures. She heavily emphasizes on the importance of correct documentation and shows a keen interest in procedural compliance and validation, sterilization, and product acceptance procedures.

Top Process Types:

Environmental Monitoring
Training Management
Batch Records
Contamination Control
Equipment Cleaning

Observation Categories

Critical

What’s a Rich Text element?

The rich text element allows you to create and format headings, paragraphs, blockquotes, images, and video all in one place instead of having to add and format them individually. Just double-click and easily create content.

Static and dynamic content editing

A rich text element can be used with static or dynamic content. For static content, just drop it into any page and begin editing. For dynamic content, add a rich text field to any collection and then connect a rich text element to that field in the settings panel. Voila!

How to customize formatting for each rich text

Headings, paragraphs, blockquotes, figures, images, and figure captions can all be styled after a class is added to the rich text element using the "When inside of" nested selector system.

Major

What’s a Rich Text element?

Static and dynamic content editing

How to customize formatting for each rich text

Headings, paragraphs, blockquotes, figures, images, and figure captions can all be styled after a class is added to the rich text element using the "When inside of" nested selector system.

Minor

What’s a Rich Text element?

Static and dynamic content editing

How to customize formatting for each rich text

Headings, paragraphs, blockquotes, figures, images, and figure captions can all be styled after a class is added to the rich text element using the "When inside of" nested selector system.