326 Burnside Street | Annapolis MD 21403
p) (301) 537-5378 | f) (410) 268-7413
email: tourault@erols.com
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As a premier provider of consulting services in the U.S. and Europe, Ms. Tourault consistently delivers the greatest depth of capabilities, expertise, and quality solutions to blood banking, device manufacturing, and pharmaceutical businesses in the following areas:

  • Good manufacturing practices (GMP) training programs for the blood community

  • Guidance for understanding and preparing 510(k) submissions to the FDA/CBER, and the reinstatement of U.S. licenses for blood establishments

  • Vendor audits for pharmaceutical manufacturers

  • Understanding FDA regulations, compliance requirements, and how to communicate effectively with the FDA

  • Quality assurance for manufacturers of blood and blood products, device manufacturers, and blood grouping reagent manufacturers

  • GMP/quality assurance programs

  • Prior Consulting Engagements Include:

    Performed an evaluation of platelet validation strategies for a large blood collection agency
    Worked with device manufacturers on 510k submissions that subsequently received clearance from FDA
    Provided guidance to a device manufacturer following issuance of a Warning Letter
    Performed a pre-FDA inspection audit. The FDA inspection result was no issuance of a 483
    Provided guidance by review of records for sale of a product line of a coagulation product in an anti-trust case
    Rated and classified Software Problem Reports and Enhancement Requests for a large blood collection agency. Trained staff to use the Health and Safety Protocol our team validated
    Performed audits of blood and plasma establishments prior to FDA and CLIA inspections. Provided on-site guidance during FDA inspections as well as aiding in the creation of a response to the 483 following the inspection
    Performed guidance during meetings with FDA following issuance of Warning Letters or following inspections

Ms. Tourault has a proven track record with a broad cross-section of clients in the blood industry to include large and small manufacturers. Her committment to her clients' success includes a committment to training clients in their respective needs.

Client training exists in the following areas:

  • Customized training programs
  • GMPs
  • Quality Assurance
  • FDA Inspection Readiness
  • Corrective Action Management
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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.




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...


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?

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