FDA WARNING_LETTER - Zhejiang Ludao Technology Co., Ltd. - August 18, 2017

The FDA inspected Zhejiang Ludao Technology Co., Ltd. from August 14 to 18, 2017, and found significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals, rendering their drug products adulterated under 21 U.S.C. 351(a)(2)(B). Key deficiencies included a failure to ensure complete laboratory records and data integrity (21 CFR 211.194(a)), with evidence of falsified analytical test results and deleted electronic data. The firm also failed to conduct identity testing for drug product components and validate supplier analyses (21 CFR 211.84(d)(1) and (2)). Additionally, the company lacked a proper written stability testing program to determine storage conditions and expiration dates (21 CFR 211.166(a)), with some batches found to be super-potent. The FDA deemed the firm's September 11, 2017, response insufficient, particularly regarding data integrity remediation and component testing. The FDA strongly recommended retaining a qualified consultant to assist with CGMP compliance and data integrity remediation. As a result of these violations, the firm was placed on Import Alert 66-40 on December 28, 2017, and faces potential refusal of admission for its articles into the U.S. and withholding of new drug application approvals. A written response detailing corrective actions is required within 15 working days.