Search Results for keywords:"Federal Food Drug and Cosmetic Act"

The Food and Drug Administration (FDA) has issued a final order denying Bernardo Garmendia's request for a hearing and has permanently banned him from providing services related to drug products. This decision stems from Garmendia's conviction for conspiracy to commit wire fraud while working at AMB Research Center, where he was involved in falsifying clinical trial documents. As of March 14, 2025, using Garmendia’s services in any drug application process incurs civil penalties for involved parties. This ruling highlights the FDA's commitment to safeguarding drug development processes.

The Food and Drug Administration (FDA) has issued an order permanently banning Jerrod Nichols Smith from providing services related to drug product applications. This decision follows his conviction on multiple felony counts of mail fraud and obstruction of justice, connected with the unlawful distribution and misrepresentation of prescription drugs. Smith's company, Cumberland Distribution, was involved in distributing drugs illegally obtained from unlicensed sources, leading to significant profit from falsified documents and drug mislabeling. After being notified, Smith did not respond or request a hearing, resulting in his debarment which prohibits him from engaging in drug product services.

The Environmental Protection Agency (EPA) has issued a final rule exempting certain pesticide residues in food from needing a tolerance level when used according to label guidelines. Specifically, residues of Pseudomonas oryzihabitans strain SYM23945 in all food commodities are exempt as they are deemed non-toxic and safe based on data evaluation. This ruling ensures there is no significant risk to human health, including infants and children. The decision, effective March 27, 2025, reiterates that no maximum permissible residue level is required for this strain when used properly.