FDA WARNING_LETTER - Volk Optical, Inc. - May 20, 2008

On April 29 through May 20, 2008, an FDA inspection of Volk Optical, Inc. in Mentor, Ohio, identified significant violations of the Quality System (QS) regulation (21 CFR Part 820) for diagnostic contact lenses and sterile disposable Vitrectomy lenses. These devices were deemed adulterated under section 501(h) of the Federal Food, Drug and Cosmetic Act.

Key violations include: 1. **Corrective and Preventive Action (CAPA):** Failure to analyze and trend quality data (e.g., complaints, returns, scrap rates) to identify nonconforming product causes (21 CFR § 820.100(a) and (b)). 2. **Complaint Handling:** Incomplete failure investigations for 19 of 19 reviewed complaints and inadequate trending of past complaints (21 CFR § 820.198(c)). 3. **Nonconforming Product Control:** Failure to identify and record the disposition of non-conforming products (21 CFR § 820.90(a)). 4. **Process Validation:** Lack of validation for ultrasonic cleaning, polishing, sealing, gluing/curing, bonding processes, and CNC mills for Class II lenses (21 CFR § 820.75(a) and (b)). 5. **Process Controls:** Failure to