EPA v. BIOZONE SCIENTIFIC AMERICA LLC

Case summary

MARCH 7, 2022 - NOTICE OF REFUSAL OF ADMISSION FIFRA 12(a)(1)(F): To sell or distribute a pesticide device that is misbranded. Specifically, the device is not labeled in accordance with FIFRA 2(q)(1) and 40 C.F.R. Part 156 in that the device is not labeled with the EPA Establishment Number of the EPA-registered establishment where it was last produced, precautionary language or directions for use provided on the label or as labeling. Additionally, the device appears to include claims that are false or misleading, pursuant to FIFRA 2(q)(1)(a) and 40 CFR ? 156.10(a)(5). FIFRA 2(a)(2)(N): Failure to file reports required by the Act. The importer or the importer's agent did not file or did not complete: A Notice of Arrival of Pesticide and Devices (NOA) EPA Form 3540-1 prior to the arrival of the shipment in the U.S. or; An electronic alternative to the NOA filed with the entry documentation via any CBP authorized electronic data interchange system.

Defendants (1)

• BIOZONE SCIENTIFIC AMERICA LLCNamed in settlement

Facilities (1)

• BIOZONE SCIENTIFIC AMERICA, LLC

  9561 SATELLITE BOULEVARD SUITE 300, ORLANDO, FL, 32837

  Registry ID: 110071234910

Statutes cited

• FIFRA 12A2N — Failure to File Reports
• FIFRA 12A1F — Device Misbranded

Enforcement conclusions (1)

• BIOZONE SCIENTIFIC AMERICA LLCentered 2022-03-07

  Primary law: FIFRA

Timeline (3 milestones)

• 2022-03-07Enforcement Action Closed
• 2022-03-07Final Order Issued
• 2022-03-09Enforcement Action Data Entered