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04-2021-1333Administrative - FormalClosedFY 2021· Region 04

EPA v. SPRY THERAPEUTICS

Unilateral Administrative Order Without Adjudication

Case summary

APRIL 8, 2021 - NOTICE OF REFUSAL OF ADMISSION FIFRA 12(a)(1)(A) To sell or distribute to any person any pesticide that is not registered under Section 3 or whose registration has been cancelled or suspended, except to the extent that distribution or sale otherwise has been authorized by the Administrator under FIFRA. Specifically, the pesticide product, PB2012, did not include the EPA Reg. No. nor EPA Est. No. FIFRA 12(a)(1)(F) To sell or distribute a pesticide device that is misbranded. Specifically, the device, Air Sanifier, is not labelled in accordance with FIFRA Section 2(q)(1) in that the label does not bear an EPA Est. No. FIFRA 12(a)(2)(N) Failure to file reports required by the Act. The importer or the importer's agent did not file 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)

  • SPRY THERAPEUTICSNamed in settlement

Facilities (1)

  • SPRY THERAPEUTICS

    923 WHITAKER ROAD SUITE G, PLAINFIELD, IN, 46168

    Registry ID: 110070923777

Statutes cited

  • FIFRA 12A1FDevice Misbranded
  • FIFRA 12A2NFailure to File Reports
  • FIFRA 12A1AUnregistered Pesticide

Enforcement conclusions (1)

  • SPRY THERAPEUTICSentered 2021-04-08

    Primary law: FIFRA

Timeline (3 milestones)

  • 2021-04-08Final Order Issued
  • 2021-04-08Enforcement Action Closed
  • 2021-04-08Enforcement Action Data Entered

Case metadata

EPA activity ID
3602481891
Case number
04-2021-1333
Lead agency
EPA
EPA region
04
Voluntary self-disclosure
No
Primary statute
Device Misbranded

Sourced verbatim from EPA ECHO Enforcement Case Report for case 04-2021-1333 . Bulk data: ICIS-FEC download summary.

This is legal information, not legal advice. Laws vary by jurisdiction and change frequently. Always verify current law with official sources and consult a licensed attorney in your jurisdiction for advice on your specific situation.