Of Counsel
138 Mineola Blvd.
Mineola, NY 11501

Phone: 516-294-0300
Fax: 516-294-0477
Email: rdanko@supplementcounsel.com

Robert Danko, Esq. is a California dietary supplement lawyer who concentrates his practice in the area of GMP regulations and FDA compliance. With decades of experience representing food and beverage manufacturers, Robert has developed an expertise in dietary supplement law and in particular, GMP compliance. Robert brings valuable and timely legal expertise in GMP issues to Collins Gann McCloskey & Barry PLLC clients to help prepare for FDA inspections and avoid potential GMP failures.

Robert, who is based in California and is part of CGMB’s growing West Coast dietary supplement law practice, offers experienced legal counsel in the areas of GMP compliance and provides legal guidance to ensure that suppliers, manufacturers and brand owners meet all FDA requirements in the manufacturing and marketing of dietary supplements. With more than 25 years of experience, Robert provides important legal advice for clients in the supplement industry including responding to 483 notices and FDA Warning Letters, preparing for FDA inspections and handling GMP citations. In addition, he works proactively with suppliers, manufacturers and brand owners nationwide to ensure that they are following all Standard Operating Procedures in the dietary supplement industry, and works to ensure compliance with all regulatory requirements to avoid any potential FDA citations, warnings and potential dietary supplement company product recalls/shut-down of operations.

Prior to joining CGMB’s dietary supplement law division as Of Counsel, Robert served as Vice President/General Counsel at Aseptic Solutions, a wholly owned subsidiary of Glanbia, Inc, a global leader in food, beverage and sports nutrition. While at Aseptic Solutions, Robert led a number of initiatives involving GMPs and regulatory compliance, with specific achievements including developing dietary supplement procedures and company guidelines to achieve full compliance with 21 CFR 111, successfully planning/establishing the company’s Dietary Supplement Laboratory, and managing the company’s Organic Certification Program.

Robert offers seasoned legal counsel on all matters surrounding GMP regulations and FDA compliance, and provides critical legal expertise in helping dietary supplement companies prepare for FDA inspections and effectively respond to 483s and FDA Warning Letters. He works with clients in the dietary supplement industry at all phases of their development and growth, and plays an important role in ensuring that clients adhere to all GMP and regulatory guidelines.

A graduate of Pepperdine University in Malibu, California, Robert received his law degree from Western State University College of Law, and has been a member of the California State Bar Association since 1988.

 

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