483 Roundup: Three Firms Cited for Design Controls, Quality
The FDA flagged three devicemakers for quality and other deficiencies observed during inspections.
Dharma Research: Dharma Research failed to validate its processes or to qualify equipment used for its dental gel, the FDA said following a March 6-18 inspection of the firm’s Miami, Florida facility.
The company failed to validate storage conditions for its Etchant gel prior to the final syringe packaging, and there was inadequate documentation of control methods, monitoring and data collection for the sealing of the prophylaxis paste cups, the agency said — noting this as a repeat observation from 2014.
Another repeat observation was failing to establish design control procedures for the Class II dental product or to provide a reference to all records related to the design and development process, such as user needs, design inputs and outputs, and design verification and validation activities.
The FDA said the company’s production processes were not developed, conducted, controlled and monitored to ensure that a device conformed to specifications.
“Your firm has failed to adequately identify hazards associated with all stages of the device life cycle, from product design to procurement to production and post-market use with the goal to estimate, evaluate, control and monitor risks associated with each life-cycle stage,” the 483 said.
Health-Chem Acquisitions: Management at Health-Chem Acquisitions failed to ensure that every functional area responsible for the design and manufacturing of hCG test strips was properly resourced for achieving quality and compliance function, the FDA said following a Jan. 17-Feb. 20 inspection of the company’s Pompano Beach, Florida plant.
Health-Chem manufactures HCD diagnostic products such as pregnancy and fertility kits, cholesterol and glucose monitoring, and diagnostics for drug and alcohol screening.
Personnel with knowledge of the firm’s market withdrawals, submissions and design controls were not present during the inspection to provide concrete responses regarding the basis for the market withdrawal of the pregnancy test, the FDA said.
The firm failed to establish design control procedures because the formal design history file was not maintained for hCG analog and digital test strip systems. There was no documented evidence that design review meetings were carried out, the agency said.
The diagnostics maker also didn’t establish the type of evaluation needed to qualify suppliers or to maintain evidence that suppliers met such requirements.
Stimwave: FDA investigators found Stimwave Technologies’ complaint handling procedures and corrective and preventive actions for its implantable pain treatment devices were not up to par, during a Jan. 29-Feb. 15 inspection of the firm’s Pompano Beach, Fla. Facility.
The company makes wireless pain relief products called the Freedom spinal cord stimulator and the StimQ peripheral nerve stimulator that target nerves causing chronic pain. Faulty devices were returned to the manufacturer for not charging, not connecting or powering on and overheating, but many of the complaints were not entered into the firm’s complaint handling system.
Software-related allegations of performance problems were not documented and handled through the firm’s complaint handling system, which meant that complaints were not evaluated to determine if the events should be reported to the FDA.
Numerous complaints of injuries from infections associated with the implanted devices, as well as problems due to the migration of the devices were reported but not immediately followed up as MDRs.
The firm’s CAPA procedures didn’t include requirements for analyzing quality data using appropriate statistical methodology to detect recurring quality problems, the 483 said, noting that the firm only began documenting returned products as of Aug. 31, 2018 until the time of the inspection.
Procedures for design change were found to be lacking because they didn’t require validation or verification of all design changes, inspectors said, pointing to software validation problems.
Read the Dharma Research Form 483 here: www.fdanews.com/08-29-19-dharmaresearchinc483.pdf.
Read the Health-Chem Acquisitions Form 483 here: www.fdanews.com/08-29-19-healthchemacquisitionsllc483.pdf.
Read the Stimwave Technologies Form 483 here: www.fdanews.com/08-29-19-stimwavetech483.pdf.
Special Issues for Medical Device Reporting Procedures Devicemakers need to consider three special issues when developing or revamping medical device reporting (MDR) procedures. Reporting to other regulators: U.S. devicemakers often report to regulators in other countries, which may have different requirements. The FDA recommends that companies develop U.S.-specific MDR procedures rather than try to establish a global procedure to meet all requirements. An alternative would be to provide the MDR procedure as a clearly defined section of a global document. The two-year malfunction “rule:” Traditionally, there has been an unwritten rule that if a company reports a malfunction and that problem doesn’t occur for two more years, it doesn’t have to report that issue anymore. The two-year period is referenced as a suggestion in the agency’s 1997 guidance on Medical Device Reporting for Manufacturers. However, in a 2011 warning letter to Animas Corp., the FDA stated that devicemakers should not blindly apply that time period and stop reporting. Instead, a company interested in ending reporting on a given issue should discuss the issue with the agency. Contract manufacturers: The 1997 MDR guidance recommended that both the devicemaker and any contract manufacturer report MDRs unless they have a written agreement that the FDA has approved that only one will report them. Make sure that if you have contract manufacturers, it’s crystal clear between you, the contract manufacturer and the FDA who is reporting MDRs. Some things can be left out of MDR procedures. For instance, the FDA no longer requires annual certifications, so the agency has recommended that devicemakers remove references to these from their procedures. The same applies to baseline reports. Device manufacturers that have references to either of these documents in their existing procedures should delete them. Excerpted from the FDAnews management report: Complaint Management for Devicemakers — From Receiving and Investigating to Analyzing Trends. |