FDA issues warning letters for CGMP violations, marketing devices for unintended uses

The US Food and Drug Administration (FDA) has cited multiple companies for marketing products for which they were not authorized and for violating current good manufacturing practices (CGMP).

Mectronic Medicale S.R.L.

On 5 August, FDA published several recent warning letters, including a letter to Italian medical device maker Mectronic Medicale. The company was cited nine quality system regulation (QSR) violations, medical device reporting violations, and for marketing products for conditions for which they were not authorized.

Mectronic Medicale manufactures CHELT, Ixyon XP, iLux Smart, iLux Plus, Doctor Tecar, Doctor Tecar Smart, and Doctor Tecar Plus devices that have been cleared to heat tissue to treat pain and muscle spasms, and to increase local blood circulation. However, FDA said the company is marketing the devices for conditions such as Carpal Tunnel Syndrome, improving healing, and boosting cellular metabolism.

“Generic devices of this type emit energy at infrared frequencies (approximately 700 to 50,000 nanometers) to provide topical heating and are intended for medical purposes including, but not limited to, temporary increase in local blood circulation and temporary relief of: muscle spasms, minor joint pain and stiffness, minor muscle pain and stiffness, and minor arthritis pain,” said FDA. “However, your firm is marketing the CHELT, Ixyon XP, iLux Smart, and iLux Plus for different specific intended uses, namely ‘for the treatment of pathologies of the musculoskeletal system such as lumbago, cervicalgia, epicondylitis, medial epicondylitis, … as well as contractures …’

“FDA is currently unaware of any clinical evidence that could support these intended uses,” the agency added.

FDA also said patients could be at increased risk of injury from using the devices for unintended purposes, such as nerve damage and muscle and skin burns. The company was also cited for not filing radiation safety product reports and annual reports per regulations since it markets medical lasers.

In addition, FDA cited Mectronic Medicale for several QSR issues, including failure to maintain design history files (DHF), establishing process validation for certain instances, establishing a process to properly handle nonconforming products, and more.

Visgeneer, Inc

Taiwanese medical device manufacturer Visgeneer was issued a warning letter for CGMP violations. FDA said the company failed to adequately establish and maintain device design validation procedures for its eBchek Blood Glucose Monitoring System.

"Specifically, your firm has no documentation of the parts or software version used in the manufacturing of the devices used for, or production records or dates of production, for units(s) used in the ‘development pilot product’ tests, electrical safety test, and EMC test,” said the agency. “Also, during the inspection, Mr. Chiu-Yi Huang (Ivan), R&D Manager, confirmed that your firm did not have the documentation for the devices used for testing.”

FDA said Visgeneer also failed to adequately establish and maintain procedures to receive, review, and evaluate complaints about their products by a designated unit. The company was also cited for failing to ensure that all the products they received from suppliers and distributors meet specified requirements.

Furthermore, FDA cited Visgeneer for failing to follow corrections and removals requirements regarding its eBuricacid/Uritouch Blood uric acid monitoring system devices. The agency noted that it failed to submit a report within 10 working days of initiating a correction or removal of the product.

"After FDA informed you on October 30, 2023, that your eBuricacid device requires a 510(k) premarket notification before marketing and distributing in the US, you informed the distributor in the US market to remove the affected product from Amazon and any other online or physical sales outlets," said FDA. "Marketing these devices in the US without marketing clearance is a violation of 21 CFR 862.9(a).

"CDRH has determined that the use of eBuricacid without FDA marketing clearance may cause temporary or medically reversible adverse health consequences, or an outcome where the probability of serious adverse health consequences is remote," the agency added. "This action meets the definition of a medical device correction or removal initiated to remedy a violation which may present a risk to health, for which you are required to submit a Report of Correction or Removal to FDA."

Oasis Medical

FDA also warned California-based drugmaker Oasis Medical for CGMP violations. The agency said the company failed to establish adequate procedures to ensure its drugs are manufactured to specification. It was also cited for failing to thoroughly investigate unintended discrepancies or batch failures or any of the components of the drug.

Oasis was also cited for not having proper laboratory controls in place to ensure its products met specifications.

"Your firm failed to establish laboratory controls that include scientifically sound and appropriate specifications, standards, sampling plans, and test procedures designed to assure that components, drug product containers, closures, in-process materials, labeling, and drug products conform to appropriate standards of identity, strength, quality, and purity," said FDA. "You also failed to establish and follow an adequate written testing program designed to assess the stability characteristics of drug products and to use results of stability testing to determine appropriate storage conditions and expiration dates."

Finally, the agency said Oasis’ quality unit (QU) failed to do its job by ensuring proper oversight of its internal and external manufacturing activities.

Warning letters

FDA issues warning letters for CGMP violations, marketing devices for unintended uses

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