Alpine Oral Care, LLC – FDA Warning Letter, Aug 13, 2008

On July 24, 28, 30, and August 4, 7, 13, 2008, the FDA inspected Alpine Oral Care, LLC in Houston, Texas, a specification developer manufacturing and distributing mouth guards and dental flossers. The inspection revealed the firm's devices are adulterated under 21 U.S.C. § 351(h) because manufacturing, packing, storage, or installation methods, facilities, or controls do not conform to the Quality System (QS) regulation (21 CFR Part 820).

Violations include: 1. Failure to establish and maintain design control procedures (21 CFR § 820.30(a)). 2. Failure to maintain a device design history file for mouth guards (21 CFR § 820.30(j)). 3. Failure to establish and maintain procedures for controlling purchased product and services, including requirements for and evaluation of foreign contract manufacturers and domestic packagers (21 CFR § 820.50). 4. Failure to establish and maintain adequate complaint handling procedures (21 CFR § 820.198). 5. Failure to establish and maintain procedures for nonconforming product control (21 CFR § 820.96(a)). 6. Failure to establish and maintain procedures for acceptance or rejection