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USDA Acts Against Peanut Corporation of America; FDA Testifies Before Congress
February 6, 2009By Ricardo Carvajal –
USDA has suspended, and proposes to debar, Peanut Corporation of America ("PCA") from “participating in government contracts or subcontracts, as well as federal non procurement programs,” among other activities. The suspension is for one year and is effective immediately. The proposed debarment would be effective for three years. PCA has 30 days to object to USDA’s actions. In its press release announcing the actions, USDA had harsh words for PCA, alleging that the firm “lacks business integrity and business honesty.”
Meanwhile, in a written statement submitted by FDA/CFSAN Director Stephen Sundlof to the Senate Committee on Agriculture, Nutrition and Forestry, FDA reiterated its confidence that the PCA facility in Georgia is the source of the current Salmonella outbreak, and confirmed that FDA’s Office of Criminal Investigations is investigating. FDA has taken the somewhat unusual step of posting the Form 483 issued at the conclusion of its recent inspection of the Georgia facility on the internet. The inspectional observations listed in the Form 483 detail numerous apparent failures to adhere to good manufacturing practice requirements.
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- 2023 IS the Year for OTC Naloxone! March 30, 2023
- What is Special about September 24, 2023 for the UDI System? March 28, 2023
- The “End of the COVID-19 Emergency and the Ryan Haight Act: Telemedicine and Next Steps” – Availability of HPM’s Presentation Deck and Recording of the Presentation March 28, 2023
- With Oral Argument in Important False Claims Act Case Fast Approaching, A Reminder of the High Stakes March 23, 2023
- HP&M Attorney Mark Tobolowsky Co-Authors Article in Human Gene Therapy Advocating for the Acceptance of Microdystrophin Expression in DMD Patients as a Surrogate Endpoint for Accelerated Approval March 19, 2023
- 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
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- Reimbursement
- Tissue Products
- Tobacco
- Uncategorized