Gasoline Storage Location Draws FDA Warning for Medsource
A container of gasoline stored next to orthopedic trays got devicemaker Medsource into hot water with the FDA and landed the firm a Sept. 24 warning letter for quality system deficiencies.
The company’s Tiverton, R.I., facility was inspected March 26 to 31 after which it received a Form 483.
The letter cites the firm for failure to establish proper storage procedures to prevent contamination, failure to establish acceptance activities for the orthopedic trays, failure to establish and maintain CAPA procedures and failure to establish a quality management system.
While the container of gasoline caught the inspector’s eye, the firm did not have a procedure for storage of medical devices. Orthopedic trays awaiting delivery to customers were stored in the same area used to inspect orthopedic trays returning to the firm after being used in surgery, the letter says.
The inspector also observed that the firm did not have any acceptance activities for manufacturing the trays, nor did the firm have a corrective and preventive action procedure.
In addition, Medsource had not established a quality management system or a system for notifying managers of quality issues.
The FDA also said that since Medsource modified the surgical trays, they are considered new devices and need to be registered.
The agency also told the company that its Optecure + CCC allograft demineralized bone matrix products are considered medical devices when combined with bone void filler.