The FDA today released a warning letter it sent to phototherapy device maker National Biological Corp. this month over issues it found during an inspection of the company’s Beachwood, Ohio-based facilities.
The federal watchdog identified 8 total violations, and requested that the company take immediate action to correct the violations.
Included in the violations were a failure to validate processes which cannot be validated by a later inspection, failure to establish and maintain procedures for identifying, recording and disposing of nonconforming products.
The agency also noted a failure to establish complaint review and investigation procedures, a failure to maintain procedures to detect recurring quality problems and a failure to have a complete risk analysis.
The final 3 violations noted by the agency included a failure to verify received and purchased product conformity, a failure to document rework and revolution activities in the device history record and a failure to establish and maintain records that its equipment is routinely calibrated, inspected, checked and maintained.
The federal watchdog also recommended the company update its correction and removal procedures, stating that its current procedure “incorrectly uses the MDR reporting criteria to determine whether a report or correction or removal is required,” according to the FDA warning letter.
The agency requested a response within 15 business days to show that it was correcting the noted violations.