Three device manufacturing facilities landed Form 483s from the FDA after inspections turned up numerous problems with their CAPA, complaint, training and MDR procedures.
Full Range Rehab: The FDA issued a Form 483 to Full Range Rehab, citing problems with its CAPA procedures, acceptance activities, record-keeping and complaint handling.
A March inspection of the company’s West Chester, Ohio, facility found the firm had no CAPA procedures. It also lacked procedures for receiving and final acceptance. The director of operations told investigators the firm simply inspected parts upon receipt without standard procedures or records for the process.
Meanwhile, the chief operating officer confirmed the company did not maintain device master records or device history records, and its procedures for handling complaints did not adequately define all customer complaints. The firm also lacked procedures for document control or quality audits.
The firm’s complaint handling procedure did not adequately define all customer complaints.
For example, the procedure did not identify notifications of the firm’s device not functioning properly as complaints. In addition, repairs of the firm’s devices, such as replacing an actuator that was no longer working, were not routinely recorded or documented.
Mb Industria Cirurgica: Cirurgica landed a Form 483 from the FDA for inadequate process validation, CAPA procedures, environmental conditions and training.
The agency issued the form following a March inspection of its facility in Paulista, Brazil. Investigators found numerous manufacturing processes for the firm’s Omiderm device had not been verified and also fell short on several procedures to control environmental conditions.
Further investigation found the firm had no procedures to ensure timely and effective assessment of events that might qualify for medical device reporting requirements. Investigators also hit the company on its CAPA procedures, finding they did not require analysis of quality data to identify existing and potential or recurring issues. It also lacked requirements to ensure all quality problems were communicated to those responsible for quality.
The firm’s complaint-handling procedure did not require timely processing all complaints, documentation of oral complaints on receipt, or evaluation of complaints to determine whether they should be reported to the FDA as adverse events.
The company’s procedures for nonconforming product did not require determining and documenting the disposition of such products, and the firm failed to implement another of its nonconforming product procedures. Industria Cirurgica had also not implemented its procedures for release of a lot of Omiderm for distribution or its procedure for equipment calibration.
Investigators also found employees responsible for the firm’s quality system demonstrated insufficient knowledge of the system, suggesting insufficient training, and the company’s training procedure did not require retraining when procedures are updated.
CarboFix Orthopedics: The FDA hit CarboFix Orthopedics on MDR submissions, anti-contamination efforts and quality audits.
The agency issued a Form 483 following a February/March inspection of the devicemaker’s Hamerkaz, Israel, facility. Investigators found the company failed to submit an MDR report within 30 days of becoming aware of potential malfunctions in a marketed device. Multiple complaints that could potentially qualify as adverse events were not reported, according to the form.
CarboFix also had no testing procedures for its implanted medical device for Endotoxin, a known contaminate, according to the FDA. Investigators further found that the facility did not perform quality audits at defined intervals.