Last week, Zydus Lifesciences confirmed the receipt of an FDA warning letter at its Waghodia plant in Gujarat, India, marking ...

The Food and Drug Administration (FDA) recently issued warning letters to two third-party nonclinical testing laboratories.

From truckloads of torn documents to avian incursions in the production plant, Granules India’s recent manufacturing ...

A drug production facility in Durham run by a Chinese company violated multiple safety regulations, according to the FDA. A ...

The U.S. Food and Drug Administration's (FDA) warning letter to Agena Bioscience, issued on March 21, 2024, marks a significant shift in enforcement priorities, targeting the improper labeling of ...

Some letters are not posted for public view until weeks or months after they are sent. Business owners have 15 days to respond to FDA warning letters. Warning letters often are not issued until a ...

Some letters are not posted for public view until weeks or months after they are sent. Business owners have 15 days to respond to FDA warning letters. Warning letters often are not issued until a ...

The U.S. Food and Drug Administration issued warning letters to two Chinese third-party testing firms on Wednesday, citing ...

The FDA has issued a warning letter to Regenerative Processing Plant after conducting an inspection of the facility. The plant manufactures two ophthalmic drug products, Regener-Eyes Professional ...

Globus Medical said it received a warning letter from the Food and Drug Administration ... guarantee that its response will satisfy the FDA and that further legal or regulatory action could ...

The firms, which provide third-party testing and validation data services to medical device manufacturers, were found to have “pervasive failures” that could lead to faulty data.

The FDA said the problems “raise concerns about the quality and integrity of data generated by the labs,” which provide third-party testing and validation data services for device firms.