FDA Warns Ohio Devicemaker Over Validations, Complaint Procedures
The FDA warned National Biological for adulterated devices 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 phototherapy devices. It also failed to properly evaluate nonconforming materials.
Investigators found the facility’s complaint procedures did not address evaluating all complaints to determine if an investigation was needed. The complaints were just assigned a failure code rather than being evaluated and investigated.