During Shutdown, FDA Continues Posting Warning Letters to Device Companies

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By Dana A. Elfin  

Oct. 11 -- Although the Food and Drug Administration has been affected by the government shutdown that began Oct. 1, the agency still is posting warning letters to regulated companies.

In the latest batch of letters to device companies, the FDA said that catheter insertion kits, blood piercing devices, surgical forceps, vascular silicon ties, class I and II nonsterile laser devices, guidewire devices, vaginal pessaries and insulin pumps were adulterated.

For example, in a warning letter posted to the FDA's website Oct. 8, Steven D. Silverman, director of the Office of Compliance at the FDA's Center for Devices and Radiological Health, told Chinese company Bang Medical Instruments Co. that its catheter insertion kits, blood piercing devices and surgical forceps were adulterated due to multiple manufacturing issues, including inadequate corrective and preventive action procedures, issues with process validation, document control problems and failure to maintain device history records. The firm was given 15 days to inform the FDA in writing of the specific steps they had taken to correct the violations, as well as an explanation of how the firm plans to prevent these or similar violations from occurring again.

Similarly, in another letter posted Oct. 8, the FDA's Silverman told Canadian company Batrik Medical Mfg. Inc. that various problems, including inadequate procedures for maintaining device history records, failure to control nonconforming product and failure to validate processes, rendered its vascular silicon ties adulterated. Silverman said a follow-up inspection would be required to ensure that the firm had taken appropriate corrective action.

In a third letter posted Oct. 8, Silverman warned Japanese company Nidek Co. about manufacturing issues with its class I and II nonsterile laser devices. Among the issues the agency cited were inadequate document control procedures, failure to maintain complaint files and establish and maintain procedures for receiving, reviewing, and evaluating complaints by a formally designated unit, as well as failure to properly control device labeling and packaging.

Meanwhile, letters posted to the FDA's website Oct. 1 targeted various companies' guidewire devices, vaginal pessary devices and penile ring devices.

In a letter signed by Silverman posted Oct. 1, he cautioned German company Epflex Feinwerktechnik Gmb that its guidewire devices were both adulterated--because of multiple violations of current good manufacturing practices--and misbranded because of the company's failure to annually register with the FDA.

Chinese company Suzhou Armocon Technology Co. received a letter from the FDA detailing problems with its Luna Beads, a vaginal pessary device, and Tor II, its penile ring devices. In the case of the firm's Luna beads, Silverman said the company failed to establish and maintain procedures to control the device's design. For example, the letter said, after receiving customer complaints regarding rust on the metal balls of the Luna Beads, the firm implemented a new design for the Luna Beads, changing the inner ball of the Luna Beads from metal balls to coated metal balls. “However,” Silverman wrote, the “firm has not conducted design validation and risk assessment for the newly designed Luna Beads.”

He also said the firm didn't indicate when it expects to complete its design validation activities and submit the validation results to the FDA. Moreover, he said, the firm didn't tell the FDA whether it planned to conduct a review of all of its products to evaluate if there are similar deficiencies among the firm's other product lines. Other manufacturing issues listed in the letter included failure to maintain adequate device history records for the Luna Bead and Tor II devices.

Silverman said the Luna Bead and Tor II devices also are misbranded due to multiple issues, including failure to establish medical device reporting procedures and failure to annually register with the FDA.

In addition, Silverman said, the firm lacked premarket approval for its Luna Beads, and also made uncleared claims about the device in promotional materials. For example, he said promotional materials for Luna Beads include uncleared medical claims asserting, among other things, that Luna Bead has a proven health benefit for women of all ages, and significantly reduces chances of incontinence and pelvic floor disorders. Silverman told the company that the uncleared medical claims should be removed from the promotional materials for Luna Beads until the firm receives FDA clearance for the product and for those intended uses.

Silverman also said that due to the serious nature of the violations, the firm's Luna Beads are subject to refusal of admission into the United States until the violations are corrected.

Medtronic MiniMed

Finally, Minneapolis-based Medtronic Inc. subsidiary Medtronic MiniMed received a warning letter in connection with the FDA's February pre-approval inspection for the company's MiniMed 530G Continuous Glucose Monitoring System. The system uses the currently marketed Paradigm Insulin Infusion Pumps as a component of the new device.

In a 17-page letter dated Sept. 19, Alberto Gutierrez, director of the Office of In Vitro Diagnostics and Radiological Health at the FDA's CDRH, told the firm that lack of compliance with the FDA's cGMP requirements, including pump leakage problems, rendered the device adulterated. In addition, Gutierrez said the device was misbranded because of flaws in the company's revised MDR procedure.

Despite the issues outlined the FDA in the letter, the FDA approved the MiniMed 530G Continuous Glucose Monitoring System Sept. 27 for people with diabetes .

In a Sept. 27 statement, Medtronic said it would make certain manufacturing accommodations consistent with the concerns raised in the FDA's Sept. 19 warning letter. Medtronic said it already has addressed many of the observations noted in the warning letter and is committed to resolving the remaining observations as quickly as possible and in accordance with the product approval requirements.

Medtronic MiniMed is based in Northridge, Calif.


To contact the reporter on this story: Dana A. Elfin in Washington at delfin@bna.com

To contact the editor responsible for this story: Brian Broderick at bbroderick@bna.com

FDA's warning letters are at http://www.fda.gov/ICECI/EnforcementActions/WarningLetters/default.htm#recent.