FDA WARNING_LETTER - Hangzhou Badi Daily Use Chemical Company - March 21, 2019

The FDA inspected Hangzhou Badi Daily Use Chemical Company from March 19-21, 2019, revealing significant CGMP violations for finished pharmaceuticals (21 CFR 210, 211), rendering drug products adulterated (21 U.S.C. 351(a)(2)(B)). Deficiencies included failure to test finished drug products for identity/strength of active ingredients (21 CFR 211.165(a)), failure to verify component identity (21 CFR 211.84(d)(1)), lack of adequate process control procedures and validation (21 CFR 211.100(a)), and absence of stability testing to support expiration dates (21 CFR 211.137(a)). Furthermore, "(b)(4) ROLL-ON" was identified as an unapproved new drug (21 U.S.C. 321(p), 355(a)), prohibiting its interstate commerce (21 U.S.C. 331(d)). "(b)(4) Stick" was misbranded (21 U.S.C. 352(c), 352(x)) due to an incomplete statement of identity and failure to disclose a domestic address for adverse event reporting, also prohibiting its interstate commerce (21 U.S.C. 331(a)). Cosmetic products were adulterated (21 U.S.C. 361(c)) due to insanitary conditions, including inadequate equipment cleaning, unsanitary facilities, and poorly designed equipment. The firm's FDA 483 response was inadequate, and repeat violations from a 2016 inspection indicated insufficient executive oversight. The company has ceased drug production for U.S. distribution. FDA issued Import Alert 66-40, and future approvals may be withheld. A CGMP consultant is strongly recommended if drug manufacturing resumes. A written response detailing corrective actions is required within 15 working days.