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10-2006-0258Administrative - FormalClosedFY 2006· Region 10

EPA v. JANSSEN PHARMACEUTICAL, INC

Final Order With Penalty

Case summary

During an October 13, 2005, import inspection, EPA found that Janssen Pharmaceutical, Inc. (Janssen), had shipped to the U.S. a pesticide in violation of the Federal Insecticide, Fungicide, and Rodenticide Act (FIFRA). On October 15, 2005, the EPA inspected a similar product again imported by Janssen and found that it too was in violation of FIFRA. The October 15 inspection showed that the product label bore three EPA pesticide producing establishment numbers with no indication of which number represented the establishment that last produced the product, and was missing the required precautionary statement, �Have the product container or label with you when calling a poison control center or doctor, or going for treatment.� Furthermore, the NOA submitted by Janssen�s import broker, BDP International, Inc., contained false and inaccurate information when compared to the actual product being imported. To gain control over the illegal shipment, the EPA issued a Stop Sale Use or Removal Order on October 20, 2005, which outlined several conditions that Janssen had to meet in order to further sell and distribute the product. This penalty action is in follow up to the October 20, 2005, Order. Janssen was very cooperative during the Stop Sale Order and the settlement negotiations.

Defendants (1)

  • WILLIAM GOODWINNamed in complaintNamed in settlement

Facilities (1)

  • JANSSEN PHARMACUETICAL INC

    2580 S 156TH ST, BLDG A, SEATTLE, WA, 98158

    Registry ID: 110012560442

Statutes cited

  • FIFRA 12A1EAdulterated/Misbranded

Enforcement conclusions (1)

  • JANSSEN PHARMACEUTICAL, INCentered 2006-04-12

    Primary law: FIFRA

    Federal penalty: $4,680

Timeline (4 milestones)

  • 2006-03-28Enforcement Action Data Entered
  • 2006-04-12Complaint Filed/Proposed Order
  • 2006-04-12Final Order Issued
  • 2007-04-16Enforcement Action Closed

Case metadata

EPA activity ID
172575
Case number
10-2006-0258
Lead agency
EPA
EPA region
10
Voluntary self-disclosure
No
Primary statute
Adulterated/Misbranded

Sourced verbatim from EPA ECHO Enforcement Case Report for case 10-2006-0258 . 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.