FDA Warns Chinese Manufacturer of ‘Magic Spray for Pain Relief’
The US Food and Drug Administration (FDA) released warning letters on Tuesday for China-based over-the-counter (OTC) drugmaker Zhuhai Aofute Medical Technology Co., Colorado-based device firm Vevazz and Dallas-based Curewave Lasers.For Zhuhai Aofute Medical Technology Co., which was placed on import alert last November, the FDA inspectors found the firm lacked identity and strength testing for each batch of its OTC product, “Magic Spray for Pain Relief.”
In addition, the inspection from last July uncovered that the company failed to adequately perform basic quality unit (QU) responsibilities, such as having adequate production and laboratory records.
“You have not demonstrated that your manufacturing process is capable of consistently producing drugs of uniform character and quality. Specifically, you have not validated your manufacturing process for ‘Magic Spray’ OTC topical liquid spray drug products,” the letter says.
FDA also says that if the company intends to resume manufacturing and shipping drugs to the US, it should provide corrective actions, including systemic remediation as well as a global assessment and remediation of all six systems of its manufacturing operations.
Vevazz
A lengthy warning letter for Vevazz also documented how the firm is not only improperly marketing low-level LED light therapy devices that have received 510(k) clearances, but also marketing unapproved devices, including a bed of LED lights and a face mask with LED lights.
For instance, the warning letter says that the Vevazz Contour was marketed as a treatment for neuropathy, which is not supported by the firm’s FDA clearances.
And while the firm argued that pain is a symptom of neuropathy, FDA says: “The treatment of neuropathy is a different intended use than the temporary relief of pain, and, therefore, different evidence is necessary to demonstrate a reasonable assurance of safety and effectiveness for a device intended to treat neuropathy. Your firm has not provided any evidence to FDA to demonstrate the Contour’s safety and effectiveness for treating neuropathy.”
FDA also says the firm could not provide documentation demonstrating evaluation and qualification of its supplier for the contract manufacture of the Vevazz LED devices labeled to treat pain, inflammation, neuropathy, and obesity as required by the firm’s unapproved procedure.
Curewave
And the warning letter sent to Curewave Lasers last month from the Office of Medical Device and Radiological Health Operations makes clear that the firm’s Curewave Medicore device is adulterated and misbranded.
FDA says the firm submitted a premarket notification for the device but the agency advised the company it’s a Class II Exempt device.
Devices under the ILY product code, according to FDA, are “intended to provide topical heating to the treatment area. However, evidence collected during our inspection demonstrates that your firm is marketing these devices with intended uses of ‘tissue regeneration’, ‘healing’ and ‘improved vascular and cellular structural integrity.’”
FDA also says the company provided no evidence to support the safety and efficacy of the CureWave laser devices. “The lack of evidence demonstrating the safety and efficacy of these claims raises public health concerns. Specifically, the risk for these devices, as advertised, is delay in definitive treatment. For example, delayed or ineffective treatment for wound care and bacterial infection can lead to loss of function, amputation, or death. Additionally, delayed or ineffective treatment for nerve damage can lead to permanent loss of function,” the letter adds.
Zhuhai Aofute Medical Technology Co., Ltd.
Vevazz LLC
Curewave Lasers LLC