National Biological Lands Warning for Improper Nonconformance Procedures, Complaint Handling

The FDA warned National Biological Corp. for failure to thoroughly investigate complaints and improper handling of out-of-spec products.

Following an inspection of the company’s Beachwood, Ohio, facility, the agency issued a warning letter noting the company did not validate numerous pieces of equipment used to manufacture its phototherapy devices. The facility failed to validate its crimping  machines, including the machine used to produce the devices.

Moreover, according to investigators, the facility had not validated the gluing/curing process it used to manufacture the devices.