EPA v. NIKKISO MEDICAL AMERICA, INC

Case summary

JANUARY 25, 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 labelled in accordance with FIFRA Section 2(q)(1) in that the product labeling does not appear to the EPA Establishment Number of the EPA-registered establishment where it was last produced. Additionally, the product label appears to include claims that are false or misleading in relation to the efficacy of the product such as Air Disinfector. FIFRA 12(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 U.S. Customs and Border Protection (CBP) authorized electronic data interchange system.

Defendants (1)

• NIKKISO MEDICAL AMERICA, INCNamed in settlement

Facilities (1)

• NIKKISO MEDICAL AMERICA, INC

  4737 EAST SHELBY DRIVE, MEMPHIS, TN, 38118

  Registry ID: 110071201731

Statutes cited

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

Enforcement conclusions (1)

• NIKKISO MEDICAL AMERICA, INCentered 2022-01-25

  Primary law: FIFRA

Timeline (3 milestones)

• 2022-01-25Final Order Issued
• 2022-01-25Enforcement Action Closed
• 2022-01-26Enforcement Action Data Entered