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 ...

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 ...

give any assurances that the FDA will be satisfied with its response or as to the expected date of the resolution of the matters included in the warning letter.” The company continued ...