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FDA, Bankruptcy, Criminal Prosecution, Forfeitures and GMPs-An Unusual Combination
June 11, 2008In a case involving a highly unusual set of facts for FDA-regulated companies, Leiner Health Products, Inc. (Leiner) is seeking to have a plea agreement approved by a Bankruptcy court. The case involves violations of Current Good Manufacturing Practices (cGMPs) for over-the-counter drugs. What also makes this case unusual is that the violation alleged in the case is not an FDC Act violation for selling adulterated or misbranded drugs. Instead, the government is apparently seeking a plea from Leiner to violations of the Mail Fraud Act under 18 U.S.C. § 1341. Also unusual is that under the proposed agreement Leiner would not have to pay any criminal fine. Instead, it would pay a ten million dollar forfeiture.
The Motion, proposed Information and Plea Agreement are available here.
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- Gun Violence Reduction Law Further Extends Moratorium on Trump-Era Rebate Rule June 27, 2022
- 10th Annual Legal, Regulatory & Compliance Forum on Dietary Supplements is Just Days Away June 24, 2022
- Corporate Liability from Employee Diversion: Costly on Many Fronts June 22, 2022
- ‘Til I Hear It From Congress: FDASLA to Direct Publication of Final OTC Hearing Aid Rules June 22, 2022
- In Bid to Curtail 180-day Exclusivity, FDA Alters Longstanding Practice and Newly Declares that Converted OTC Products Are Not “Listed Drugs” June 21, 2022
- Big Molecule Watch Blog
- Bloomberg BNA Health Care Blog
- Drug and Device Law Blog
- Eye on FDA
- FDA Matters
- Harvard Law Bill of Health
- IN VIVO Blog
- Internet Drug News.com
- Lachman Consultants Blog
- Medical Devices Today
- Orange Book Blog
- The Orange Book Insights Blog
- Pharma IQ
- Pharmalot
- SCOTUS Blog
- The Volokh Conspiracy
- WLF Legal Pulse
- Advertising and Promotion (Federal Trade Commission)
- Advertising and Promotion (OPDP)
- Animal Drugs and Feeds
- Biosimilars
- Cannabis
- cGMP Compliance
- Consumer Product Safety Commission
- Controlled Substances
- Cosmetics
- COVID19
- Current Affairs
- Dietary Supplements
- Drug Development
- Drug Enforcement Administration
- Enforcement
- FDA News
- Foods
- Foods and Dietary Supplements
- Fraud and Abuse
- Government Pricing
- Hatch-Waxman
- Health Care
- Health Privacy
- Import/Export
- In Vitro Diagnostic Devices
- Jobs
- Medical Devices
- Miscellaneous
- Orphan Drugs
- OTC Drugs and Cosmetics
- Prescription Drugs and Biologics
- Product Jurisdiction and Combination Products
- Reimbursement
- Tissue Products
- Tobacco
- Uncategorized