Case Results

Dietary Supplement Inspection

November 2017

Late 2017 a dietary supplement private labeler was inspected by FDA. This was their second inspection in two years. At the first inspection there were various observations noted by the FDA inspector. During this second inspection there were zero observations issued. The dietary supplement private labeler and our firm had been working diligently to establish a compliance program that would address all the requirements under FDA good manufacturing practices.

According to the FDA if you are responsible for the label, then your company is also responsible to ensure that the manufacturer is producing what you requested and that your contract manufacturer is complying with good manufacturing practices. This particular supplement private labeler thought that the manufacturer was responsible for all "good manufacturing practices".

After consistently implementing new written policies and procedures and training the employees on what their requirements are under the regulations this client was able to breathe easy before, during and after the inspection. 

Practice area(s): Other

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Lisa Capote

Ms. Capote is the founder and Managing Partner of Capote Law Firm. She founded the minority, woman owned law firm in 2006 with the goal to provide quality service to FDA regulated companies. Since that time her practice has grown to include other US federal agencies as well as an international trade component.

Awards

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10.0Lisa Capote

Awards

Our attorneys are AV rated since 2012 and bilingual. The firm has been recognized as International Trade Law Firm of the Year in Florida by Global Law Experts and Best FDA Compliance Law Firm - Florida by US Business News. Our attorneys have a 10 out of 10 Rating with Avvo.

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