Former FDA consumer safety officer joins Amin Talati

Former FDA consumer safety officer joins Amin Talati

As an FDA investigator, Tamara Brey conducted good manufacturing practice inspections of medical device, drug, cosmetic and food manufacturers and distributors.

Tamara Brey, former Chicago district Food and Drug Administration (FDA) consumer safety officer, has joined the law firm Amin Talati, LLC in Chicago, a full-service FDA, FTC, patent, trademark, licensing and litigation firm, as an associate attorney focusing on food and drug import, labels, and customs matters.

As an FDA investigator, Brey conducted good manufacturing practice inspections of medical device, drug, cosmetic and food manufacturers and distributors. She conducted complex inspections in the bioresearch monitoring program for CDRH, CDER, and CBER including inspections of clinical investigators and institutional review boards. In addition, Brey investigated complaints of injuries and illnesses related to FDA-regulated products, and conducted a sensitive special investigation of multiple deaths caused by a medical device. Brey was recognized for her work at FDA having been awarded a FDA commissioner’s special citation and two FDA commissioner recognition awards.

“We have enhanced our ability to serve our food, dietary supplement, drug and medical device clients,” said Ashish R. Talati, chair of Amin Talati’s food and drug practice. “Brey is a great addition to our team. She offers clients practical FDA experience that will be of tremendous help as we are seeing an increase in GMPs, imports and customs enforcement,” Talati added.

During her tenure at FDA, Brey was also a member of the FDA foreign cadre. As a foreign inspector, Brey inspected and applied U.S. regulations to firms’ operations in Canada, Scotland, Great Britain and Italy. FDA granted a level II certification in medical device inspections to Brey, attesting to her expertise in CDRH regulations and inspection techniques.

Brey earned her J.D. from Loyola University Chicago School of Law. She also holds a B.S. in biomedical engineering from Marquette University. Brey possesses a certificate in clinical trials management from the University of Chicago Graham School of general studies.

 

Hide comments

Comments

  • Allowed HTML tags: <em> <strong> <blockquote> <br> <p>

Plain text

  • No HTML tags allowed.
  • Web page addresses and e-mail addresses turn into links automatically.
  • Lines and paragraphs break automatically.
Publish