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# Latest FDA Warning Letters
- URL: https://www.fdaweb.com/latest-fda-warning-letters-8/
- Published: 2020-01-21T12:00:00.000Z
- Updated: 2026-09-14T15:59:25.000Z
- Author: David McFarland
- Tags: FDA Policy/General, #legacy-id-D5145890

FDA has posted its latest batch of Warning Letters. They can be accessed by clicking on the link following each letter.

**CGA Limited** Laventille, Trinidad & Tobago (12/19): FDA inspected the company in May and cited significant GMP violations for finished pharmaceuticals. For example, the company failed to test samples of each component for identity and conformity with all appropriate written specifications for purity, strength, and quality. The company also failed to have, for each batch of drug product, appropriate laboratory determination of satisfactory conformance to final specifications for the drug products. To view the letter, click [here](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/cga-limited-589028-12192019?ref=fdaweb.com).

**Curewave Lasers** Dallas, TX (12/12): FDA inspected the company in September and determined that it is manufacturing the CureWave Medicore without an approved PMA or IDE in place. According to FDA, the firm’s Web sites are promoting the device for claims that are not within the scope of the current exemption from 510(k) notification. FDA says CureWave has provided no evidence supporting the safety and efficacy of its laser devices as marketed on its Web sites. To view the letter, click [here](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/curewave-lasers-llc-593692-12122019?ref=fdaweb.com).

**Tismor Health and Wellness** Kingsgrove, Australia (12/5): FDA inspected the company in May and cited significant GMP violations for finished pharmaceuticals. For example, the company failed to exercise appropriate controls over computer or related systems to assure that only authorized personnel institute changes in master production and control records. The company also failed to establish written procedures for production and process control designed to assure that the drug products manufacture have the identity, strength, quality, and purity they purport to possess. To view the notice, click [here](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/tismor-health-and-wellness-pty-limited-588104-12052019?ref=fdaweb.com).

**Vevazz** Eaton, CO (12/26): FDA inspected the firm in June and determined that its low level LED light therapy device (Vevazz Contour) are adulterated and misbranded. The inspection found that there have been major changes to or modification of the device’s intended uses — dermatological esthetic treatment for reducing circumference of hips, waist, and thighs; and providing topical heating for the purpose of elevating tissue temperature for the temporary relief of minor muscle and joint pain, arthritis, stiffness or muscle spasms. The agency says statements on the company’s Web sites and in materials collected during the inspection suggest that the device is intended for treating neuropathy, inflammation, and other uses, which constitute major changes or modifications to its intended uses. To view the letter, click [here](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/vevazz-llc-592118-12262019?ref=fdaweb.com).

**Zhuhai Aofute Medical Tech** Guangdong Sheng, China (1/9): FDA inspected the firm in July and cited significant GMP violations for finished pharmaceuticals. For example, the company failed to have, for each batch of drug product, an appropriate laboratory determination of satisfactory conformance to final specifications for their drug products. The company also failed to establish an adequate quality control unit with the responsibility and authority to approve or reject all components, drug product containers, closures, in-process materials, packaging materials, labeling, and drug products. To view the letter, click [here](https://www.fda.gov/inspections-compliance-enforcement-and-criminal-investigations/warning-letters/zhuhai-aofute-medical-technology-co-ltd-590945-01092020?ref=fdaweb.com).