St. Shine Optical Co., Ltd. – FDA Warning Letter, May 25, 2013

On May 20-25, 2013, an FDA inspection of St. Shine Optical Co., Ltd. in Taipei Hsien, Taiwan, revealed that their contact lenses are adulterated under 21 U.S.C. § 351(h) due to non-conformity with cGMP requirements of the Quality System (QS) regulation (21 CFR Part 820).

Violations included: 1. **Process Validation (21 CFR 820.75(a)):** Failure to validate processes with a high degree of assurance, specifically regarding final lens power measurements and objective evidence for relationships between manufacturing parameters. The firm's response was deemed inadequate due to lack of documentation and evidence of implementation. 2. **Corrective and Preventive Action (CAPA) (21 CFR 820.100(a)):** Failure to establish and maintain CAPA procedures that include analyzing all sources of quality data to identify nonconforming product causes. The firm's response was inadequate, lacking a plan and evidence of corrective actions. 3. **Design Verification (21 CFR 820.30(f)):** Failure to establish and maintain procedures for verifying device design, specifically confirming design output meets design input for the full range of lens power. The firm's response was inadequate, lacking evidence of corrections and procedure revisions. 4. **Process