Warning Letter Roundup: FDA Flags Four Devicemakers
The FDA issued warning letters to four device manufacturers for a range of issues, including a failure to seek pre-market approval, to apply for modified intended uses, and quality violations.
SyncThink: The FDA told a Boston eye-movement monitor manufacturer to stop marketing the device as a tool for assessing concussions and other head injuries.
SyncThink, maker of the Eye-Sync device, did not apply for the required premarket approval or investigational device exemption for the Eye-Sync for the head-trauma assessments, which represent a new use for device, the FDA said in a warning letter.
The Eye-Sync has been cleared by the FDA as a prescription device for recording and analyzing eye movements to identify visual impairment. On its web site, SyncThink is promoting Eye-Sync for on-the-spot evaluation of potential concussions, particularly among football players; that amounts to “a major change or modification to its intended use,” the letter said.
The company web site lists Texas, Iowa State and Stanford as universities that have adopted the “revolutionary” Eye-Sync for concussion assessment in their athletic programs. The device has been written about in the mainstream media as cutting-edge technology for assessments of sports head injuries.
The device resembles a set of virtual-reality goggles, which are connected wirelessly to a suitcase-sized, portable input processing unit.
QLRAD Netherlands: The FDA moved to block the importation and sale of a Dutch device designed to immobilize the prostate during radiation treatments to target it more accurately and minimize damage to surrounding tissue.
QLRAD Netherlands, maker of the RectalPro Endorectal Balloon, did not apply for the required premarket approval or investigational device exemption for the balloon, the FDA said in a warning letter.
QLRAD promoted the device for use with radiation therapy on its web site and in brochures distributed at medical conferences in San Antonio and Boston, the FDA said.
Hebei Pukang Medical Instruments: The FDA cut off imports from a Chinese manufacturer of hospital beds, stretchers and operating-room tables after an inspection discovered multiple violations of quality standards, the agency said in a warning letter.
The FDA said the company, Hebei Pukang Medical Instruments, of Baoding, fell short of compliance with current good manufacturing practice requirements, including:
- Lack of written procedures for design control;
- Failure to maintain history records of the manufacture of products to ensure they meet requirements for their production;
- Failure to maintain complaint files and to follow company procedures for the investigation of complaints; and
- Failure to conduct audits of the effectiveness of the company’s quality control system.
The FDA said it was taking steps to block imports from the company until the problems are fixed. It also said it may inform other federal agencies, potentially affected the awarding of contracts, and that it will not approve applications from the company to market any new products related to the shortcomings until they are resolved.
Gesellschaft für lichttechnische Erzeugnisse: A German sunlamp manufacturer failed to measure up to several quality standards in an inspection of its plant in Berlin, and the FDA moved to bar imports from the company to the United States, the agency said in a warning letter.
In its inspection of the company, G L E Gesellschaft für lichttechnische Erzeugnisse, the FDA said it determined the manufacturer:
- Failed to establish and maintain controls over the design of its lamps to ensure they meet specified requirements, specifically for its 1000-watt high-intensity UV lamps;
- Failed to set up procedures for undertaking corrective and preventative action; and
- Failed to maintain complaint files, and to establish procedures for review of complaints by a designated unit within the company.
The FDA rejected as inadequate responses to the findings that were received from the company.
Read the SyncThink warning letter here: www.fdanews.com/09-06-17-SyncThink.pdf.
Read the QLRAD warning letter here: www.fdanews.com/09-06-17-QLRAD.pdf.
Read the Hebei warning letter here: www.fdanews.com/09-06-17-Hebei.pdf.
Read the GLE Sunlamps warning letter here: www.fdanews.com/09-06-17-GLEsunlamps.pdf. — Gregory Roberts
Medical Device Complaint Management Basics Maintaining an effective complaint handling system requires attention to detail, robust internal audits and a solid training program. Three of the regulatory requirements related to this system — complaints, MDRs and CAPA — consistently appear in the top five most frequent citations in warning letters issued to device manufacturers. While MDR citations have been relatively flat since 2012, citations related to complaints and CAPA have seen a slight upswing since that time. This means that these are areas that FDA investigators scrutinize during each and every inspection. Under such close examination, any slip-ups are almost certain to be caught. There are a few steps that companies can take to ensure the regulatory success of their complaint handling systems. One is simply to check the procedures. A complaint handling system that meets all QSR requirements must include a large number of procedures, so a check to confirm that all of these are under document control, as laid out in 21 CFR 820.40 – Document Controls, can help catch any details that may have fallen by the wayside. Likewise, a requirement-by-requirement review of each procedure against the pertinent regulations can help to ensure that the complaint handling and MDR procedures are fully compliant. For every sentence in the regulations, you should have a place where it’s addressed in your procedure, explains Dan O’Leary, president of Ombu Enterprises, a company offering training and execution in operational excellence, focused on analytic skills and a systems approach to operations management. “If you have multiple procedures and work instructions, which often happens, make sure you review them together to make sure that everything is covered and that there are no inconsistencies.” Keeping up with training also can be a challenge. It’s essential that everyone involved in the complaint handling process understands how those processes work and who is responsible for. All employees who could potentially be involved in complaint handling must be trained in complaint procedures, and all training must be documented and training records maintained. Excerpted from the FDAnews book: Medical Device Complaint Management |