On November 27, 2024, the company announced it had received a Complete Response Letter (CRL) from FDA for its NDA, and shortly thereafter it received a Warning Letter, which the company disclosed ...

The FDA issued a warning letter to iRhythm in 2023 after a facility inspection revealed issues that included failing to seek clearance before making changes to the Zio system and marketing it for ...

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 ...

according to the warning letter. Dexcom has ceased distribution of G7 sensors with the component, but the company’s response did not address affected G6 sensors. J.P. Morgan analyst Robbie ...

Brassica also failed to collect samples for environmental and ... the FDA now wants the company to specify in its response to the warning letter whether it plans to resume manufacturing drugs ...

facilities and is working on a written response. The diabetes devices maker on Friday said the warning letter doesn’t restrict its ability to produce, market, manufacture or distribute products.