Mary Ann Tourault - Consulting to Blood Establishments and other FDA Regulated Industries

326 Burnside Street | Annapolis MD 21403
p) (301) 537-5378 | f) (410) 268-7413
email: tourault@erols.com

MARY ANN TOURAULT
Certifying Your Blood Establishment

Offering consulting services, audits, and educational programs for companies and blood establishments seeking FDA compliance and regulatory guidance, and who wish to leverage their capabilities to the fullest extent.

With over 30 years extensive experience in the blood banking industry, Mary Ann Tourault has emerged as a leading independent consultant to blood and plasma establishments and pharmaceutical manufacturers in the areas of regulatory guidance and compliance.

With an American and international client base, Ms. Tourault has
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	Who Checks the Checker by Mary Ann Tourault At the conclusion of an FDA inspection, many times the Investigator issues a FDA-483 to list the observations noted during the inspection. There is no guarantee that an item listed is a true deficiency from regulations or a deviation in Current Good Manufacturing Practices (cGMPs). The observations noted are one person's opinion, which should be based on documented evidence. read more...

ASK THE EXPERT

1) How do I respond to FDA Form 483?

What is the significance of FDA Form-483?

Response to the FDA 483

Who Checks the Checker?

2) How do I respond to a warning letter?

3) How do I respond to a license suspension?

4) How do I perform a 510(k) submission?

ANSWER: ASK MARY ANN TOURAULT

AUDITS:

Timely and relevant examination of Good Manufacturing Practices (GMP) is critical to blood bank establishments and pharmaceutical manufacturers. Ms. Tourault's broad expertise allows her to perform a full lifecycle of audits, allowing clients to concentrate on their core business.

Audits can be performed in the following areas: click here...

BLOOD BANK CERTIFICATION

As a premier provider of consulting services in the U.S. and Europe, Ms. Tourault consistently delivers the greatest depth of capabilities, and quality solutions to blood banking, device manufacturing, and pharmaceutical businesses in the following areas:

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