Andrew K Haack

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Investigation Details

Last Issued Date

September 18, 2019

Conversion Rate

% Conversion

No. of 483’s Issued

Warning Letters Issued

Countries Inspected

USA

FDA Investigators having one site common

Taichun Qin , Peter S Kessier , Christopher R Czajka , Uttaniti Limchumroon , Kenneth O Gee , Peter S Kessler , Karthikeyan Kanakarajan

Detailed Analysis

Approach:

Inspector Haack approaches audits with a primary concern for sterilization and cleanliness. He is meticulous in examining the construction of aseptic processing areas, the usage of disinfectant agents, and personnel hygiene. He emphasizes on preventing any form of contamination in the manufacturing process

Profile:

FDA inspector Andrew K Haack maintains a significant focus on facility design and cleanliness. He closely scrutinizes aseptic processing areas, particularly the contamination risks due to poor design and inadequate pre-processing disinfection. He evidences a strong emphasis on sterile equipment and personnel hygiene in efforts to ensure optimal cleanliness

Top Process Types:

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.