DexCom received a warning letter from the Food and Drug Administration following inspections of its San Diego and Mesa, Ariz. facilities and is working on a written response. The diabetes devices ...

Dexcom made a significant design change to a component used in its sensors and did not adequately validate the change, ...

The Food and Drug Administration recently issued a Warning Letter concerning unauthorized modifications made to a previously cleared medical ...

With its active pharmaceutical ingredient (API) facility “in a state of disrepair,” manufacturer Aspen Biopharma Labs’ operations have ground to a halt in the U.S., according to a recent FDA reprim | ...

Warning letters often are not issued until a company ... Program (FSVP), which ensures imported food meets U.S. safety standards. The warnings, sent to Radhaswamy Inc. (dba Raja Foods LLC) and ...

The February 26 warning letter is related to the agency’s inspection ... to ensure against product contamination or patient safety concerns. Subsequently it resumed operations.