FDA WARNING_LETTER - Zhuhai Aofute Medical Technology Co., Ltd. - July 18, 2019

The FDA inspected Zhuhai Aofute Medical Technology Co., Ltd. from July 15-18, 2019, identifying significant CGMP violations for finished pharmaceuticals, rendering their "Magic Spray for Pain Relief" adulterated. The firm failed to perform critical quality control tests, including identity and strength testing for finished products and suitability testing for incoming components (21 CFR 211.84).

The company lacked an independent and effective quality unit, with the Factory Director also acting as Quality Director, and failed to maintain adequate production and laboratory records, including routinely discarding original raw data. Manufacturing processes were not adequately controlled; the firm lacked an ongoing program for monitoring process control and had not validated its manufacturing process for "Magic Spray," failing to provide validation protocols or adequate written procedures. The water system used for cleaning non-dedicated equipment was also unvalidated, failing to ensure water quality suitable for pharmaceutical use.

Furthermore, "Magic Spray for Pain Relief" is an unapproved new drug and misbranded. Its formulation and labeling are inconsistent with the External Analgesic Tentative Final Monograph (TFM), combining active ingredients and indications not proposed in the TFM. The product lacks a Drug Facts panel (21 CFR 201.66) and fails to disclose a domestic address or telephone number for adverse event reporting (21 U.S.C. 352(x)).

The FDA recommends retaining a qualified consultant to