FDA Comissioner Responds to Investigation of Agency’s Oversight of Tainted Syringe Factory
The Food and Drug Administration’s newly sworn commissioner promised a more aggressive approach to product safety in response to a ProPublica and Chicago Tribune report about the agency’s oversight of a North Carolina plant that produced syringes contaminated with bacteria.
“This incident underscores my belief that it is critically important for the FDA to take an aggressive approach to inspections and maintain vigilance in ensuring that manufacturers fully comply with their regulatory, legal and moral obligations to ensure that the products they produce for the American people are safe and effective,” Dr. Margaret Hamburg said in a statement issued Saturday. “I intend to make this a top priority as commissioner of the FDA.”
Hamburg, an expert in bioterrorism and community health, was confirmed in late May. She starts the job as the agency faces high-stakes challenges in food and medical-device safety. Numerous reports have concluded that FDA resources haven’t kept pace with demands placed on the agency.
In the case of AM2PAT, which produced the contaminated syringes, the FDA ignored guidance in its own operations manual to investigate the plant just weeks before tainted devices reached the hands of medically fragile patients.
Read our full coverage here.
Get Updates
Our Hottest Stories
- The 182 Percent Loan: How Installment Lenders Put Borrowers in a World of Hurt
- IRS Office That Targeted Tea Party Also Disclosed Confidential Docs From Conservative Groups
- Medicare Drug Program Fails to Monitor Prescribers, Putting Seniors and Disabled at Risk
- On Victory Drive, Soldiers Defeated by Debt
- The Most Important #Muckreads on Rape in the Military
- Everything We Know About What’s Happened Under Sequestration
- The Story Behind Our Hospital Interactive
- Is Obama Delivering on His Promise of a “21st Century” Approach to Drugs?
- Lifting the Veil on Dangerous Prescribing
- FAQ: What You Need to Know About Prescriber Checkup
- IRS Office That Targeted Tea Party Also Disclosed Confidential Docs From Conservative Groups
- The 182 Percent Loan: How Installment Lenders Put Borrowers in a World of Hurt
- How the IRS’s Nonprofit Division Got So Dysfunctional
- Everything We Know About What’s Happened Under Sequestration
- On Victory Drive, Soldiers Defeated by Debt
- Medicare Drug Program Fails to Monitor Prescribers, Putting Seniors and Disabled at Risk
- Is Obama Delivering on His Promise of a “21st Century” Approach to Drugs?
- Intern vs. Mayor: Battle Bares Bloomberg's Argument for Secrecy
- The Most Important #Muckreads on Rape in the Military
- The Story Behind Our Hospital Interactive






