A Medical Device Daily
Heamacure (Montreal) reported receiving a warning letter from the FDA citing what it called “certain document deficiencies” relating to two marketed devices whose sales were $258,000 in 2005.
It said that the letter contained no safety issues regarding the devices and it does not hamper marketing of the devices. Additionally, it said that the letter does not relate to its “current activities to build a new Hemaseel HMN fibrin sealant manufacturing plant.”
Haemacure said it has begun the effort to remedy the deficiencies and has communicated its plans to the agency.
Haemacure “intends to work closely with the FDA to show its commitment and progress in addressing the items raised in the warning letter,” it said in a statement.
Haemacure develops biological adhesives, biomaterials and surgical devices for the acute surgical wound care market. It also operates offices in Sarasota, Florida, through a wholly owned subsidiary.