FDA WARNING_LETTER - Shanghai Hua Yue Packaging Products Co., Ltd. - August 28, 2014

On December 24, 2014, the FDA issued a Warning Letter to Shanghai Hua Yue Packaging Products Co., Ltd. following an inspection from August 25-28, 2014. The inspection revealed that the firm's surgical equipment covers and surgical sponge counters are adulterated and misbranded.

Violations of the Quality System regulation (21 CFR Part 820) include: 1. Failure to validate the (b)(4) process used for surgical sponge counters, specifically lacking validation protocols and execution, as required by 21 CFR 820.75(a). 2. Failure to control and monitor production processes to ensure device conformity, as required by 21 CFR 820.70(a). For example, the firm failed to address temperatures exceeding established limits in its (b)(4) process, with working data records showing out-of-specification temperatures on multiple days.

The devices are also misbranded under 21 U.S.C. § 352(t)(2) due to a significant violation of Medical Device Reporting (MDR) requirements: 3. Failure to develop, maintain, and implement written MDR procedures, as required by 21 CFR 803.17.

The FDA requires a written response within fifteen business days detailing corrective actions, including documentation and a timetable for systemic problem resolution. Failure