• AI
  • Molecular Imaging
  • CT
  • X-Ray
  • Ultrasound
  • MRI
  • Facility Management
  • Mammography

Nycomed receives warning from FDA

Article

Contrast firm Nycomed Amersham of Princeton, NJ, received a warning letter from the Food and Drug Administration in September, according to the company. The warning came after a June inspection by the FDA of the firm's Arlington Heights, IL,

Contrast firm Nycomed Amersham of Princeton, NJ, received a warning letter from the Food and Drug Administration in September, according to the company. The warning came after a June inspection by the FDA of the firm's Arlington Heights, IL, radiopharmaceutical manufacturing facility. It cited Nycomed Amersham for neglecting to maintain FDA standards in the clean room in which NeoScan, indium DTPA, and thallous chloride are manufactured.

In addition, the letter raised concerns about Nycomed Amersham's ability to confirm the sterility of the agent technetium Tc 99m following reprocessing procedures, as well as the company's lack of standard protocols for cleaning and maintaining manufacturing equipment. The company is working closely to resolve the FDA's concerns, and there has not been any interruption of product deliveries, according to Carol Perlman, Nycomed spokesperson.

Recent Videos
Employing AI in Detecting Subdural Hematomas on Head CTs: An Interview with Jeremy Heit, MD, PhD
Pertinent Insights into the Imaging of Patients with Marfan Syndrome
What New Brain MRI Research Reveals About Cannabis Use and Working Memory Tasks
Current and Emerging Legislative Priorities for Radiology in 2025
How Will the New FDA Guidance Affect AI Software in Radiology?: An Interview with Nina Kottler, MD, Part 2
A Closer Look at the New Appropriate Use Criteria for Brain PET: An Interview with Phillip Kuo, MD, Part 2
How Will the New FDA Guidance Affect AI Software in Radiology?: An Interview with Nina Kottler, MD, Part 1
A Closer Look at the New Appropriate Use Criteria for Brain PET: An Interview with Phillip Kuo, MD, Part 1
Teleradiology and Breast Imaging: Keys to Facilitating Personalized Service, Efficiency and Equity
Current and Emerging Insights on AI in Breast Imaging: An Interview with Mark Traill, MD, Part 3
Related Content
© 2025 MJH Life Sciences

All rights reserved.