483 Roundup: Three Device Facilities Hit for Procedural Deficiencies
The FDA cited two device manufacturers and an importer after inspections identified issues with procedures, including product acceptance, complaint handling and medical device reporting.
Fendental MFG: The specification developer and initial importer based in Medley, Florida, drew a Form 483 from the FDA for procedural issues, including complaint handling, after an inspection in December.
The firm did not have a purchasing control procedure or recorded evaluation of its contract manufacturer and own-label product suppliers, making it unable to ensure products and services it received conform to specifications.
It also failed to implement its acceptance procedure for receipt, sampling and storage of products. The firm did not document incoming acceptance activities for any finished devices received.
Fen Dental also had an inadequate complaint handling procedure. It did not require investigation of events that must be reported to the FDA, including the assessment of whether a device failed specifications; whether the device was used for treatment or diagnosis; and any relationship of the device to the event. Its record retention period for complaint files was also inadequate, the agency said.
In addition, one of the firm’s medical device reporting procedures did not require the electronic submission of MDR event reports.
SafetyFix Medical Technologies: The FDA issued the Saint Louis, Missouri device manufacturer a Form 483 for device record issues and procedural failures following a November inspection.
The investigator found observed that the firm’s device master record (DMR) for fixation screws did not define certain specifications, including for packaging, labeling, acceptance criteria and quality assurance.
The device history record for the same product also did not have documentation of primary labeling, and the agency said the facility had shipped loose, unlabeled fixation screws since 2016.
The firm also had design validation problems. It lacked objective evidence to show that its easy out screw design was validated using initial production units, lots, batches or their equivalents. The risk analysis was also inadequately documented, as its product design failure modes and effects analysis was unsigned, undated and only in a draft form.
In addition, the firm did not have adequate requirements that must be met by its suppliers. It accepted a contract manufacturer without confirming the supplier could meet product specifications and it lacked documentation to show that a consulting firm it employed was evaluated and approved as a supplier of services.
The firm also lacked written medical device reporting procedures.
Geri-Gentle Corporation: A December inspection of Geri-Gentle Corporation’s South Plainsfield, New Jersey facility earned the company a Form 483 from the FDA, citing a lack of supplier requirements and incoming product acceptance procedures.
The agency’s investigator found that the firm did not have any written procedures in place to define requirements for suppliers, contractors and consultants, and did not have any procedures for monitoring their performances. It also had no written quality agreements or contracts for quality control in place for them.
The firm also lacked written procedures for receiving acceptance activities. For example, it did not define the acceptance activities required to be performed when receiving finished devices for requirement conformity, such as inspections, label reviews, tests and reviewing certificates of analysis. It also did not document the acceptance or rejection of incoming finished devices.
The firm did not properly establish written procedures that describe how the firm will prevent product mix-ups by controlling non-conforming finished products that it might receive from suppliers or contractors.
In addition, complaint review and evaluation procedures, as well as written procedures for corrective and preventative action and medical device reporting, were not adequately established.
Read the three Form 483s here: www.fdanews.com/03-16-18-Three483s.pdf.
Service Report or Complaint? One of the most confusing issues medical device manufacturers face when servicing their products is determining when a service issue qualifies as a complaint and whether the event must be reported to the FDA. Servicing is the maintenance and repair of medical devices and falls under 21 CFR 820.200 – Servicing. The intent of the regulations is to ensure that servicing is correctly performed and verified according to the company’s specifications, and that the serviced device is suitable for the intended use. The regulations require devicemakers to document service reports and include information about the device serviced, the date of service, type of service, test and inspection data, and device identification number. Devicemakers need a system for screening repair and service reports to determine whether they should be logged as complaints. Although not every service report is a complaint, a service report initiated as the result of a complaint needs to be cross- referenced in the complaint handling system. If a manufacturer receives a service report representing an adverse event, the report is automatically deemed a complaint and needs to be processed accordingly. All deaths and serious injuries require investigation, regardless of whether it was alleged that the device contributed to the adverse event. For 90 percent of the market, field service is a devicemaker’s main interface with the customer. Field service representatives are a manufacturer’s eyes and ears and should be trained to recognize when a service issue qualifies as a complaint and how to follow the company’s complaint management SOP. Excerpted from the FDAnews management report: Complaint Management for Devicemakers: From Receiving and Investigating to Analyzing Trends. |