Zhejiang Langhua Pharmaceutical Co., Ltd. ('Langhua Pharmaceutical'), a wholly-owned subsidiary of Viva Biotech Holdings ('Viva Biotech'), underwent a cGMP (Current Good Manufacturing Practices) ...

His areas of experience include handling complex quality control operations, regulatory compliance, and leadership of large ...

The integration of AI and cloud technologies is transforming pharmaceutical manufacturing regulations, focusing on safety, efficiency, and global harmonization.

A quality management system (QMS) can often become bloated and unwieldy. This expert helps you understand key QMS basics and ...

March 13, 2025 /PRNewswire/ -- Valcare Medical Inc., a leading innovator in transcatheter-based mitral solutions, today announced the U.S. Food and Drug Administration (FDA) has approved the AMEND™ ...

Starting on March 10, 2025, all businesses dealing with Class A medical devices must submit CMDN applications exclusively through the eServices Portal System. The FDA issues a CDMN to confirm that a ...

DexCom received a warning letter from the Food and Drug Administration following inspections of two of its plants.

The warning letter identified issues in manufacturing processes and quality management system at Dexcom's facilities ... containing "observations" that FDA inspectors "deem to be objectionable." ...

In the warning letter, the FDA cited deficiencies in the response ... non-conformities in manufacturing processes and quality management system. The warning letter does not restrict the company ...

The Food and Drug Administration has labeled a recall of Philips’ Tack Endovascular Systems as a Class l, which is the most serious kind of recall. There have been 20 reported injuries and no ...

along with the applicable quality management systems. Imricor is executing a modular review process with the FDA, whereby modules covering various aspects of the company’s products are submitted ...

Smith+Nephew said it submitted its technology, called the TESSA spatial surgery system, to the FDA for 510(k) clearance. The company said that, if cleared, TESSA (tracking-enabled spatial surgery ...