483 Roundup: FDA Flags Three Firms for GMP Failures
The FDA cited devicemakers in Sweden, Germany and China for GMP and other lapses, including inadequate design history files and complaint handling.
ScandiDos: Inadequate design transfer procedures and lax documentation were among the problems uncovered at devicemaker ScandiDos during an FDA inspection at the firm’s Uppsala, Sweden facility.
The company develops the Delta4 family of products, a treatment dose verification system. A 2018 release of the Delta Phantom, Delta SW and common firmware was distributed without the signatures for all listed participants, which conflicts with the firm’s standard operating procedures, the Form 483 said.
The FDA said the firm’s procedures don’t adequately address the documentation, evaluation, segregation and disposition of non-conforming material, because there was no documentation for acceptance or rejection of incoming product.
In addition, device history records were not properly maintained. The FDA investigator said a review of device history records for the Delta4 Phantom between July 2016 to July 2018 found that at least 11 DHRs didn’t include the dates of manufacture, the primary identification label, and the unique device identifier attached to the device.
The DHRs didn’t include or refer to the location of acceptance records that demonstrated the device was manufactured in accordance with the device master record, the FDA said.
Rapid Biomedical: FDA investigators found sloppy medical device reporting procedures and a lack of software validation during an inspection of Rapid Biomedical’s manufacturing plant in Bayern, Germany.
The facility’s MDR procedures didn’t include a system for timely identification, communication and evaluation of events that may be subject to MDR requirements, the agency said in a Form 483 report.
In addition, software used in the firm’s production and quality system was not validated and documented. The facility had used the software since 2005 for manufacturing, creating device history records, traceability and other quality management activities.
Rapid Biomedical’s sampling plan for incoming quality inspections was not based on a sound statistical rationale, because random sample sizes were chosen, the FDA said.
Modern Medical Equipment Manufacturing: Poor stability studies, inadequate complaint records and failure to document design inputs and outputs were among the quality system failures discovered during an FDA inspection of Modern Medical Equipment Manufacturing’s Guangdong, China facility.
The agency’s investigators found that stability studies covering a disposable general electrode didn’t cover all environmental conditions listed in the product labeling and didn’t provide a justification for not verifying the functionality of the device for the full range of conditions listed on the label. For example, testing records didn’t include humidity conditions, the agency said.
The company also failed to investigate a customer complaint about a malfunctioning device that came in contact with a patient’s face and “generated burn risks,” the Form 483 said, noting that the company didn’t follow up with the patient to determine if a medical device report should be submitted to the agency.
Corrective and preventive action records were also found to be inadequate in that CAPAs opened during an FDA inspection in July 2018 were not addressed.
In addition, simulation testing conducted during design validation of the disposable electrode was not conducted on porcine kidney and liver as reported to the FDA in the 510(k) submission, the FDA said.
Read the ScandiDos Form 483 here: www.fdanews.com/09-27-19-scandiDosabd483.pdf.
Read the Rapid Biomedical Form 483 here: www.fdanews.com/09-27-19-rapidbiomedicalgmbh483.pdf.
Read the Modern Medical Equipment Manufacturing 483 here: www.fdanews.com/09-27-19-modernmedicalequipmanultd483.pdf.
Establishing a classification system for complaints helps organize your analysis. The customer is complaining the device is deficient in meeting one or more essential design output areas including: identity; quality; durability; reliability; safety; effectiveness; and performance.
If you are going to use this classification method, make sure your complaint SOPs clearly define each type and staff are trained to make decisions based on those definitions.
Ultimately, the devicemaker must make a key decision about each complaint: Does the complaint allege a serious incident — one that might have led or might lead to a death, a serious deterioration of someone’s state of health or a threat to public health?
If the answer is yes, the complaint must be reported to the FDA or other regulator based on their regulations. If the complaint is determined to be “nonserious,” it does not need to be reported but it must be recorded, investigated and classified for analysis purposes.
It’s the way you use the results of this analysis that regulators emphasize. They want to know that you are tracking and identifying any significant increase in frequency or severity or other outlier uncovered in complaints and that you are using that information to make continual improvements.
Effective complaint management is a complex undertaking, involving staffing, training, data storage, trend analysis, reporting, information sharing, and meeting federal and international quality standards.
Complaint management involves all levels of a devicemaker’s business: manufacturing, research, customer service, sales, field service, quality assurance, regulatory affairs, all the way up to the executive suites where the big decisions are made.
Excerpted from the FDAnews management report: Complaint Management for Devicemakers — From Receiving and Investigating to Analyzing Trends.