The latest Form 483 represents the second recent FDA citation for Zydus. Last month, the agency posted another Form 483 issued after a March inspection of Zydus’ facility in Matoda, India.

Importantly, FDA also states that timely Form FDA 483 responses that include “appropriate corrective and preventive actions could impact FDA’s determination of the need for subsequent Agency ...

The inspection concluded with a Form 483 containing several observations. Capricor said it has submitted its responses to the FDA, none of which required material changes to the cGMP process or ...

The FDA has released a copy of its Form 483, which outlines observed conditions at the New England Compounding Center in Framingham, Mass. The NECC is under investigation for contaminated products ...

Summary I am downgrading Capricor Therapeutics, Inc. stock from Strong Buy to Hold due to FDA Form 483 risks from a Pre-License Inspection of its manufacturing facility.

“The FDA is releasing the FDA Form 483s from three inspections conducted at Abbott Nutrition’s facility on Sept. 16-24, 2019, Sept. 20-24, 2021, and Jan. 31-March 18, 2022.

In the 2024 Form 483s, the FDA deemed certain of the company’s devices, including cranial perforators, disposable cottonoid patties, strips, and collagen-based products, to be out of compliance ...