Inspectors found 111 open tickets for software defects categorized as catastrophic or severe patient harm. Several safety ...

Warning letters often are not issued until a company ... At the conclusion of the inspection, the FDA issued a Form 483, Inspectional Observations, to the facility, highlighting the need for ...

Among the issues detailed in a Form 483 notice issued by the agency ... the notice was not deemed adequate, so the FDA moved ahead with a warning letter. In a regulatory filing, Applied said ...

As part of its enforcement activities, the Food and Drug Administration sends warning letters to entities under its jurisdiction. Some letters are not ...

According to a recent report, 79% of FDA 483 Warning Letters issued in 2016 cited data integrity. In their guidance on data integrity and compliance with CGMP, the FDA issued their ALCOA definition of ...

The FDA has issued a warning letter related to BD Pyxis automated medication dispensing systems — technology that was part of ...

Viatris disclosed that its manufacturing facility in Indore, India, was issued a warning letter from the FDA, which banned 11 ...

Zoetis' statement notes that the FDA's action is not a "warning," but is a "'Dear Vet' letter which serves as a safety update." Veterinarian technician Justin Jones prepares a syringe with a ...

Indoco Remedies said it is in touch with the regulator regarding matter. "We will work with the USFDA to resolve these issues ...