FDA WARNING_LETTER - Xiantao Tongda Non-woven Products Co., Ltd. - July 26, 2015

An FDA inspection of Xiantao Tongda Non-Woven Products Co., Ltd. in Xiantao, China, from July 25-26, 2015, revealed that the firm's sterile surgical gowns and masks are adulterated because their manufacturing methods, facilities, or controls do not conform to the Quality System (QS) regulation (21 CFR Part 820). Key violations include: 1) Failure to establish and maintain procedures for controlling environmental conditions (21 CFR 820.70(c)), with observations of trash, debris, holes in walls/doors, and soiled materials. 2) Failure to establish and maintain procedures for controlling storage areas to prevent contamination and damage (21 CFR 820.150(a)), noting materials stored outside, soiled components, and unclean bins. 3) Failure to establish and maintain procedures to prevent product contamination by substances (21 CFR 820.70(e)), with employees not following gowning/hygiene requirements. 4) Failure to adequately control nonconforming product (21 CFR 820.90(a)), as defective masks were discarded without proper labeling. 5) Failure to establish and maintain equipment calibration procedures (21 CFR 820.72(a)), with unlabeled calibration status. Additionally, the firm failed to fulfill annual establishment registration and device listing requirements for fiscal year 2015, rendering devices misbranded under section 510 of the Act. The firm's responses to the FDA 483 were deemed inadequate, lacking sufficient detail on recurrence prevention, verification, and implementation documentation. Consequently, devices are subject to refusal of admission into the U.S. The firm must provide a written response within fifteen business days detailing corrective actions, prevention plans, and a timetable, with documentation.