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 AccuStride System is intended to enhance surgical outcomes for proximal phalanx and metatarsal arthroplasty.

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

Bloomage, a global leader in hyaluronic acid and other bioactive substance innovations, has successfully passed the GMP on-site inspection by South Korea's Ministry of Food and Drug Safety (MFDS) with ...

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 ...

The warning letter identified issues in manufacturing processes and quality management system at Dexcom's facilities in San Diego ... A Form 483 is a type of agency report containing "observations" ...

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 ...

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 ...