FDA cites company making 'baby switching' protection kit

A Lakewood, NJ, company selling a kit that uses umbilical cord identification tags to prevent "baby switching" has received an FDA warning letter stating that sterilization procedures at its plant are inadequate.

In a letter dated Feb. 28 to Prosec Protection Systems and posted to the FDA's website this week, the agency lists 10 areas of concern, including issues surrounding the company's computer system.

The FDA says the company does not even have "an adequate organizational structure to ensure that critical aspects of the quality system are performed. Further, your management representative has not established a quality unit where designated employees are responsible for ensuring the quality of your firm's assembly and sterilization processes for infant umbilical clamps."

The letter says the company's computer system has not been validated to ensure it is capable of "storing or saving critical data, such as complaints, CAPA reports, and nonconformances."

The company was given 15 days to respond.

- check out the FDA's warning letter