Florida-based Biolife drew a Form 483 with four observations following a June 2017 FDA inspection. The investigator flagged the Sarasota facility’s inadequate design change documentation and medical device reporting procedures.
The firm had failed to report information from customer complaints to the FDA that appeared to meet the definition of adverse events, the agency said.
The facility also lacked procedures for corrective and preventive actions, and the firm failed to take appropriate action to prevent the recurrence of quality problems. One CAPA initiated for out-of-specification results during calibration of equipment, said the equipment had been out of tolerance for a fourth consecutive year.