Two devicemakers, Merit Medical Systems ($MMSI) and PhotoMedex ($PHMD) have received FDA warning letters over what the agency has deemed misbranded and adulterated products made at their respective facilities.
Merit got a missive from the FDA regarding modifications to the hydrophilic coating process for the Merit Laureate hydrophilic guidewire after an inspection of the company's facility in Galway, Ireland, in September. In the Jan. 30 letter, the agency informs the company that the guidewires are adulterated and misbranded, and the modification "could significantly affect the safety or effectiveness of the devices."
For its part, Merit says it is committed to making quality products and will work with the FDA to resolve the warning letter. The Irish facility remains open.
Separately, skin health company PhotoMedex received its letter, dated Jan. 26, after an August inspection of its Montgomeryville, PA, plant. During their visit, FDA staff determined that the company's GraftCyte moist dressing, Complex Cu3 intensive hydrating gel and lamin hydrating gel are adulterated "in that the methods used in, or the facilities or controls used for, their manufacture, packing, storage, or installation are not in conformity with the current good manufacturing practice requirements," the letter states.
The letter points to several problems; for example, the company did not ensure the packaging and sterilization processes for the GraftCyte moist dressings were adequately validated. Although the company issued a response to the FDA in September about this problem, the agency said it could not determine its adequacy at this time.
Also, FDA inspectors determined that the company's wound dressings are misbranded because it didn't "adequately develop, maintain and implement written [Medical Device Reporting] MDR Procedures, as required," the letter states.