SHANGHAI APOLO MEDICAL TECHNOLOGY CO., LTD. – FDA Warning Letter, Sep 8, 2011

On February 23, 2012, the FDA issued a Warning Letter to Shanghai Apolo Medical Technology Co., Ltd. following an inspection from September 5-8, 2011. The inspection revealed that the firm's Intense Pulsed Light (IPL) Systems and accessories, classified as medical devices, were adulterated under 21 U.S.C. § 351(h) due to non-conformity with Quality System (QS) regulation (21 CFR Part 820) and misbranded under 21 U.S.C. § 352(o) for failure to notify the FDA of intent to market.

Key violations included: 1. **Design Validation (21 CFR 820.30(g)):** No documentation for validation of display module and controller software. 2. **Design Change Control (21 CFR 820.30(i)):** Lack of objective evidence for documentation and verification of design changes (e.g., IPL-HS-300 chassis). 3. **Complaint Handling (21 CFR 820.198(a)):** Inadequate procedures failing to assess reportable events, define complaints comprehensively, or require essential complaint record details. 4. **Environmental Controls (21 CFR 820.70(c)):** Inadequate procedures for