Newsletter - November 9, 2023
One Manufacturer Linked to 26 Product Recalls
In the last 2 weeks, the FDA has recalled 26 over-the-counter (OTC) eye drop products sold at major pharmacies such as CVS, Rite-Aid, Target, Walmart, and others, all apparently linked to one manufacturer. The eye drops are suspected to be contaminated and their use poses a risk of infection in the eyes...Read More
FDA Clarifies the Process to Appeal Rejection of Export Certificate Request
When the FDA refuses to issue export certificates for certain medical devices, the requesters can appeal the process. A new guidance document released this week describes the process for such appeals. Export certificates from the FDA are critical for manufacturers’ ability to export US-approved devices to other countries...Read More
One Manufacturer Linked to 26 Product Recalls
In the last 2 weeks, the FDA has recalled 26 over-the-counter (OTC) eye drop products sold at major pharmacies such as CVS, Rite-Aid, Target, Walmart, and others, all apparently linked to one manufacturer. The eye drops are suspected to be contaminated and their use poses a risk of infection in the eyes...Read More
FDA Clarifies the Process to Appeal Rejection of Export Certificate Request
When the FDA refuses to issue export certificates for certain medical devices, the requesters can appeal the process. A new guidance document released this week describes the process for such appeals. Export certificates from the FDA are critical for manufacturers’ ability to export US-approved devices to other countries...Read More
