FDA WARNING_LETTER - Suzhou Armocon Technology Co. Ltd - July 11, 2013

On July 8-11, 2013, an FDA inspection of Suzhou Armocon Technology Co., Ltd. in Jiangsu, China, found their Vaginal Pessary (Luna Beads) and Tor II (penile ring) devices to be adulterated and misbranded. The firm failed to conform to Quality System regulation (21 CFR Part 820) and Medical Device Reporting (MDR) requirements (21 CFR Part 803).

Key violations include: 1. **Design Control (21 CFR 820.30(a)):** No written design control procedures for Luna Beads, a Class II device. A design change (metal to coated metal balls due to rust complaints) lacked design validation and risk assessment. The firm's response was inadequate, lacking a complete procedure, completion timeline, and review of other products. 2. **Software Validation (21 CFR 820.70(i)):** The (b)(4) software used for serial number generation and tracking since 2011 was not validated, and no protocol existed. The firm's submitted procedure did not address software validation. 3. **Finished Device Acceptance (21 CFR 820.80(d)):** No written procedures for final device inspection. The Tor II final inspection documentation was missing verification checks for all acceptance criteria. 4. **Device History Records (DHR