Warning Letter Roundup: FDA Warns Firms for Misbranding, Quality Issues

The FDA issued warning letters to three devicemakers, citing misbranding and significant quality deficiencies.

Dexcowin: The FDA was not impressed with Korean devicemaker Dexcowin’s responses to a Form 483 it received following an August 2017 inspection of its facility in Seoul. The FDA received two responses from the manufacturer of portable dental X-rays, but then issued a 13-item warning letter.

The company’s devices were deemed to be misbranded because the Korean devicemaker failed or refused to furnish material or information on medical device reporting, and it had not established records of the results of tests for electronic product radiation safety.

The firm also failed to immediately report accidental radiation occurrences in at least two instances. The warning letter noted that the two incidents still had not been reported.

“Due to an influx of battery complaints, your firm switched battery suppliers. However, your firm did not process this corrective action through its CAPA system,” the FDA said. The agency said the firm’s response that it would include all 2017 CAPAs in an upcoming review was insufficient because a retrospective review was warranted.

Device validation procedures didn’t include predefined methods, operating conditions or acceptance criteria to ensure the device conformed to user needs and intended uses, the FDA said.

The inspection revealed inadequate procedures for identifying, documenting, validating and verifying design changes before they’re implemented. The agency said the firm’s response did not measure up because it failed to include a retrospective review of other design changes to ensure they were appropriately validated and verified.

The firm had no documentation that testing equipment was qualified for its intended purpose, and it had not maintained device history records.

Document controls were also found to be questionable. For example, the company made updates to procedures on numerous occasions without documenting the date the procedure was updated.

The FDA said it would refuse entry of the company’s products into the United States until all non-conformances are corrected.

Laser Dental Innovations: FDA investigators uncovered numerous quality system deficiencies during a December 2017 inspection of Laser Dental Innovations’ San Jose, California plant.

The firm was hit with a Form 483 at the end of the inspection, but the agency was not satisfied with the response, and issued a warning letter to the laser fiber optic surgical device manufacturer.

The quality system failures ranged from inadequate corrective and preventive actions, failure to maintain complaint files, failure to establish procedures to control the design of devices, failure to ensure that all products received conform to requirements, and failure to establish procedures to ensure that device history records are maintained in accordance with the device master record.

The FDA inspector observed that the firm failed to document several CAPAs, and that records didn’t include a root cause analysis or investigation details. Moreover, no details were provided in the response to the 483 on how the problems would be remedied for complaints associated with broken or improperly functioning collets in the LiteSaber handpieces.

Design history files for the LifeSaber 10mm hand piece and StarLite Fiber Optic devices didn’t include records for design validation or design verification, and the company told the investigator that the records “did not exist.”

Laser Dental Innovations also failed to establish supplier contracts or supplier evaluations.

The warning letter notes that the firm had not conducted an internal quality system audit since 2011.

Opternative: The FDA handed Opternative a warning letter after a review of its website found it was marketing an online eye examination mobile medical app device without marketing clearance.

The agency cited the firm for failing to secure pre-market approval for the app as well as for misbranding because the company failed to notify the FDA it was introducing the device to the market.

The FDA demanded that Opternative immediately cease marketing the product.

Read the three warning letters here: www.fdanews.com/03-16-18-ThreeWLs.pdf.