FDA WARNING_LETTER - Wickimed Medical Equipment Manufacturing Co., Ltd. - September 14, 2021

The FDA issued a Warning Letter to a Chinese manufacturer of Class II Sterile Single Use Disposable Electrodes following an inspection from September 6-14, 2021. The inspection revealed the devices are adulterated under 21 U.S.C. § 351(h) due to non-conformity with Quality System regulation (21 CFR Part 820) and misbranded under 21 U.S.C. § 352(t)(2) for failing to provide required information.

Key violations include: 1. Failure to establish and maintain complaint handling procedures (21 CFR 820.198(a)), specifically regarding receiving complaints from US distributors and providing full English translations of procedures. 2. Failure to adequately validate processes, such as sterilization (21 CFR 820.75(a)), lacking detailed information and objective evidence. 3. Failure to establish and maintain adequate design control procedures (21 CFR 820.30(a)) for US-bound devices. 4. Failure to identify product acceptance status (21 CFR 820.86), leading to unsterilized products labeled as "Sterile" and no retrospective review for released unsterilized product. 5. Failure to establish and maintain adequate document control procedures (21 CFR 820.40), with uncontrolled documents found