Wally's Natural Products, Inc. – FDA Warning Letter, Jul 15, 2009

On February 17, 2010, the FDA issued a Warning Letter to Wally's Natural Products, Inc. following inspections on June 25 and July 15, 2009. The firm manufactures ear candles, which the FDA classified as adulterated and misbranded devices.

The ear candles are adulterated because the firm lacks an approved premarket approval (PMA) or investigational device exemption (IDE) application. They are misbranded due to failure to submit a 510(k) premarket notification, maintain current establishment registration, or list the device. The FDA also cited the device as misbranded under section 502(j) because it is dangerous to health, citing six Medical Device Reports (MDRs) involving ruptured tympanic membranes and burns, two specific to Wally's Ear Candles. Furthermore, the firm failed to establish written procedures for MDRs, as required by 21 CFR 803.17.

The inspection also revealed significant Current Good Manufacturing Practice (CGMP) violations under 21 CFR Part 820 (Quality System regulation). These include: 1. Failure to establish and maintain design control procedures (21 CFR 820.30). 2. Failure to establish and maintain procedures for design changes, specifically unvalidated safety feature additions (21 CFR 820.30(i)). 3. Failure to establish