# FDA WARNING_LETTER - SHANGHAI APOLO MEDICAL TECHNOLOGY CO., LTD. - September 08, 2011

Source: https://www.keypedia.com/records/warning_letter/shanghai-apolo-medical-technology-co-ltd/4dcb5d67-ba69-4176-a847-b107f295d1f3

> FDA WARNING_LETTER for SHANGHAI APOLO MEDICAL TECHNOLOGY CO., LTD. on September 08, 2011. Product: Devices. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: SHANGHAI APOLO MEDICAL TECHNOLOGY CO., LTD.
- Inspection Date: 2011-09-08
- Product Type: Devices
- Office Name: Department of Health and Human Services
- Summary: 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

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