FDA WARNING_LETTER - Zhejiang Tiansong Medical Instrument Co., Ltd - May 15, 2014

On October 8, 2014, the FDA issued a Warning Letter to Zhejiang Tiansong Medical Instrument Co., Ltd. following an inspection from May 12-15, 2014. The firm manufactures forceps and endoscopes, which are classified as medical devices.

The inspection revealed the Tiansong 4 mm Rigid Endoscope 0° 30° 70° Cystoscope is adulterated because the firm lacks an approved premarket approval (PMA) application or an investigational device exemption. It is also misbranded for failure to submit a 510(k) premarket notification.

Furthermore, the devices are adulterated as manufacturing, packing, storage, or installation methods do not conform to Quality System (QS) regulation (21 CFR Part 820). Specific violations include: 1. Failure to establish and maintain CAPA procedures (21 CFR 820.100(a)), evidenced by un-updated procedures after a nonconformance and inadequate investigation of a nonconformance. 2. Failure to establish and maintain design validation procedures (21 CFR 820.30(g)), lacking acceptance criteria for design validations and undocumented evaluation of design validation data for endoscope A0322. 3. Failure to document validation activities and results where processes cannot be fully verified by subsequent tests (21 CFR 820.7