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.
The agency also took issue with the company’s procedures for nonconforming materials. The procedures for such materials did not require evaluations, including determining the need for an evaluation, for all nonconformances, as required by 21 CFR 820.90.
The inspection further found that 500 nonconformances listed as scrap, return to vendor or “use as is” were not evaluated to determine if an investigation was needed, and 14 nonconformances in the facility log were not assigned an initial or final disposition.
The agency also took the company to task for its handling of complaints. Company procedures for complaints did not address whether an investigation was needed, and complaints were assigned a failure code rather than being evaluated and investigated. Furthermore, the facility’s purchasing and vendor requirements did not list consultants and contractors or off-the-shelf components it uses.
The FDA also hit National Biological for violating risk analysis requirements. The company failed to incorporate several potential hazards from postmarket data into its risk analysis documents, such as complaints indicating potential risks from sharp edges and incorrect timer readings.
Investigators found the company did not properly calibrate the heat gun used for solder sleeve assembly for its phototherapy device, and the records listed no calibrations by personnel.
Lastly, the company maintained incomplete device history records that failed to properly document rework and reevaluation activities. Three of the six nonconformance reports documenting rework could not be tied to a device history record.