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03-2017-0142Administrative - FormalClosedFY 2017· Region 03

EPA v. JUBILANT CADISTA PHARMACEUTICALS, INC.

Final Order With Penalty

Case summary

On June 8, 2017, Region III entered into a Consent Agreement with, and issued a Final Order to Jubilant Cadista Pharmaceuticals Inc., settling violations of RCRA Subtitle C that EPA inspectors observed during an inspection of the company's facility in Salisbury, MD ( Facility ). The settlement will ensure that hazardous waste will be properly contained and managed in the future. The Facility manufactures generic pharmaceuticals in a tablet or capsule form, and is required to comply with the Resource Conservation and Recovery Act (RCRA) and the federally-authorized Maryland Hazardous Waste regulations. RCRA is designed to protect human health and the environment by providing for the safe management of such hazardous wastes. During the inspection, and through subsequent communications, the EPA Inspector observed that the Facility: (1) operated a hazardous waste treatment, storage, and disposal facility without a permit or interim status; (2) failed to keep hazardous waste containers closed except as needed to add or remove waste; (3) failed to maintain job titles and descriptions for employees responsible for hazardous waste management; (4) failed to prepare and maintain an adequate contingency plan, and (5) failed to submit a timely and complete biennial report. The Company has agreed to pay a penalty of $35,000 to settle the enforcement action. The Consent Agreement and Final Order initiate and resolve this enforcement action. EPA informed Maryland's Department of the Environment ( MDE ) of the action by letter on December 20, 2016 and received no objection.

Defendants (1)

  • JUBILANT CADISTA PHARMACEUTICALS, INC.Named in complaintNamed in settlement

Facilities (2)

  • JUBILANT CADISTA PHARMACEUTICALS, INC.

    207 KILEY DR, SALISBURY, MD, 21808

    Registry ID: 110033139609

  • JUBILANT CADISTA PHARMACEUTICALS, INC.

    207 KILEY DRIVE, SALISBURY, MD, 21801-2249

    Registry ID: 110033139609

Statutes cited

  • RCRA 3002Standards Applicable to Generators of Hazardous Waste

Enforcement conclusions (1)

  • JUBILANT CADISTA PHARMACEUTICALS, INC.entered 2017-06-08

    Primary law: RCRA

    Federal penalty: $35,000

Timeline (4 milestones)

  • 2017-06-08Complaint Filed/Proposed Order
  • 2017-06-08Final Order Issued
  • 2017-06-15Enforcement Action Data Entered
  • 2017-07-06Enforcement Action Closed

Case metadata

EPA activity ID
3601075526
Case number
03-2017-0142
Lead agency
EPA
EPA region
03
Voluntary self-disclosure
No
Primary statute
Standards Applicable to Generators of Hazardous Waste

Sourced verbatim from EPA ECHO Enforcement Case Report for case 03-2017-0142 . 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.