Westone Laboratories Incorporated – FDA Warning Letter, Jul 12, 2012

On July 2, 10, and 12, 2012, an FDA inspection of Westone Laboratories Incorporated in Colorado Springs, Colorado, identified significant violations regarding their Oto-Ease patient lubricant, classified as a device. The device was deemed adulterated under section 501(h) of the Act due to non-conformity with Quality System (QS) regulation (21 CFR Part 820) and misbranded under section 502(o) for failure to notify the agency of intent to introduce the device into commercial distribution.

Key violations include: 1. **Supplier Controls (21 CFR 820.50):** Failure to establish and maintain procedures for purchased products and services, including evaluating suppliers, maintaining records of acceptable suppliers, and documenting specified requirements. 2. **Complaint Handling (21 CFR 820.198(a)):** Absence of procedures for receiving, reviewing, and evaluating complaints, and failure to document oral complaints or determine reportable events. 3. **Acceptance Activities (21 CFR 820.80(a)):** Lack of documented acceptance activities for receiving, in-process, and finished Oto-Ease products, including dates, results, and signatures. 4. **Environmental Controls (21 CFR 820.70(c)):** Failure to establish procedures for controlling environmental conditions to prevent