Search Results for keywords:"Director's Order

The Environmental Protection Agency (EPA) issued a notice denying a petition to overturn a Consent Agreement and Proposed Final Order involving the Frederick-Winchester Service Authority and Frederick County Sanitation Authority. This decision was made after reviewing a petition that claimed false statements were made regarding economic benefits and pollution control practices by the respondents. The EPA determined that these statements were not materially false and did not warrant setting aside the order or holding a hearing. The case details, including the order, are accessible online for public review.

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 Bureau of Industry and Security (BIS), part of the U.S. Department of Commerce, issued a temporary order to deny export privileges for 180 days to several entities, including Kirill Gordei and Apelsin Logistics Inc. This decision was made because they were involved in shipping U.S. goods to Russia, bypassing U.S. export rules using false documents in collaboration with other companies. The investigation revealed significant and deliberate violations, such as transshipping a Mass Spectrometer and other goods to Russia without the necessary licenses. The order aims to prevent further violations and serves as a warning to others to avoid transactions with these entities.

The Drug Enforcement Administration (DEA) has revoked the DEA registration of Xubex Community Pharmacy in Casselberry, Florida. This decision was made because the pharmacy dispensed controlled substances, specifically Schedule II drugs like oxycodone and hydromorphone, without prescriptions. The DEA considered these actions a threat to public health and safety, demonstrating that the pharmacy cannot be trusted to comply with legal requirements. Furthermore, the pharmacy did not request a hearing to dispute these conclusions, leading to the default revocation of its registration.

The Food and Drug Administration (FDA) issued an order banning Jonathan Corbett Cosie from importing any drugs into the United States for 10 years. This decision follows his conviction for two federal felonies related to selling misbranded, unapproved drugs, including some that were falsely labeled and sold without a prescription. Mr. Cosie was notified of his debarment and given the opportunity to request a hearing, but he did not respond, waiving his right to contest the decision. The ban is effective as of March 13, 2025.

The U.S. Department of Energy has issued a Prohibition Order that restricts the acquisition and use of certain bulk-power system (BPS) electric equipment from China because of national security concerns. This order aims to prevent foreign adversaries from potentially exploiting these equipment vulnerabilities, especially in areas critical to defense facilities. It specifically targets equipment like transformers and circuit breakers operating at 69 kV or higher if they are manufactured or supplied by entities under China's influence. Violation of this order may result in significant civil or criminal penalties.

The Pecan Promotion, Research, and Information Order was established to help boost the pecan industry in the United States. It introduces a system to collect assessments from producers and importers to fund marketing campaigns and research aimed at increasing demand for pecans. The rule sets up a governing Board to oversee these activities and requires a referendum after three years to decide on the continuation of the order. While most of the industry supports this program, there are concerns about the financial burden on producers due to existing marketing orders.

The Food and Drug Administration (FDA) has issued an order permanently banning John Warrington Kosolcharoen from working with companies that have approved or pending drug product applications. This decision resulted from his felony conviction for fraudulently selling an unapproved stem cell product, ReGen, and making misleading claims about its safety and effectiveness. Mr. Kosolcharoen was given the chance to challenge the debarment but did not respond in the provided timeframe, leading to a waiver of his right to a hearing on the decision. During his debarment, any business that employs him for related services could also face penalties.

In the Federal Register notice titled "Ibrahim Al-Qawaqneh, D.D.S.; Decision and Order," the DEA sought to revoke Dr. Ibrahim Al-Qawaqneh's registration due to his exclusion from federal health care programs after pleading nolo contendere to a charge of offering unlawful Medi-Cal remuneration. Despite being given a chance to defend himself, the DEA found that Dr. Al-Qawaqneh failed to take full responsibility for his actions, which led to doubts about his trustworthiness. Consequently, his DEA Certificate of Registration was revoked to ensure compliance with laws regulating controlled substances.

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.