Government Agency Enforcement

Defend both entities and individuals (pharmacy, wholesaler, clinic, RPH, INT, TCH, DR) against enforcement actions by the BOP, DEA, FDA, DHCS, etc. alleging violations related to:

• Any violation of state or federal law;

• Controlled substances dispensing and violating Corresponding. Responsibility;

• Sterile and non-sterile compounding;

• Alleged manufacturing, FDA Form 483’s and FDA Warning Letters – compounding of unapproved drugs;

Develop mitigation strategies in response to initial investigations by government agencies to reduce the likelihood or severity of future enforcement action;

Navigate through audits and investigations, in requests for statements, records, and other information;

Represent at Hearing against Interim Suspension Orders and Accusations;

Aid & Assist during Inspections, Written Notices, Orders of Correction, Citations & Fines, and Informal Office Conferences;

Litigate against government-imposed civil monetary penalties and licensure sanctions;

Petition for reductions of penalty, modification of sanctions, early termination of probation, And reinstatement of licensure;

Appeal against denials of licensure, of individual or facility.