FDA’s latest whitepaper shows how scalable quality management investments in pharma reduce costs, improve reliability, and ...

The U.S. Food and Drug Administration (FDA) issued a final rule on Jan. 31, 2024, to amend the medical device current good manufacturing practice requirements of the quality system regulation ...

FDA has just published a 101-page rule titled “ Medical Devices; Quality System Regulation Amendments,” finalizing the February 2022 proposed rule of the same name.

Bloomage, a global leader in hyaluronic acid and other bioactive substance innovations, has announced it successfully passed ...

In a regulatory filing on Monday, Integra LifeSciences (IART) said that on December 19, 2024, a subsidiary received a warning letter from the U.S. FDA. The warning letter relates to quality system ...

The FDA's Quality Management System Regulation aligns U.S. standards with ISO 13485 for medical devices, promoting global consistency in quality management.

Aside from the key points outlined in the warning letter, the FDA claimed that Nuowei “does not operate an effective quality system” and called on the company’s management to “immediately ...

2. An analyst poured acid in a trash bin containing drug quality documents, and an employee said the same analyst has destroyed documents on KF titration curves and balance. 3.

STOUGHTON, Mass., May 19, 2025 /PRNewswire/ -- Massachusetts based Trax Surgical, LLC, an orthopedic product development and distribution company principally serving the needs of the orthopedic ...