FDA WARNING_LETTER - Bingbing Pharmaceutical Co., Ltd - May 10, 2019

The FDA issued a Warning Letter to Bingbing Pharmaceutical (Hubei) Co. Ltd. following a May 7-10, 2019, inspection, identifying significant current Good Manufacturing Practice (CGMP) violations that render their finished drug products adulterated under 21 U.S.C. 351(a)(2)(B). Key deficiencies include the firm's failure to maintain production, control, or distribution records for at least one year after expiration, with critical manufacturing documentation and retain samples lost during a facility transfer (21 CFR 211.180(a)). The company also released OTC drug products to the U.S. market without appropriate laboratory determination of active ingredient identity and strength prior to release (21 CFR 211.165(a)). Furthermore, the quality control unit failed to ensure CGMP compliance and meet specifications (21 CFR 211.22), admitting to shipping products without complete testing due to cash flow issues. Lastly, the firm failed to maintain adequate written records of complaints, providing inaccurate investigation details (21 CFR 211.198(b)). The FDA noted inadequate data integrity and strongly recommended retaining a qualified consultant. Consequently, the firm was placed on Import Alert 66-40. Bingbing Pharmaceutical must respond within 15 working days with comprehensive corrective actions to prevent further regulatory action, including potential refusal of admission for their products and withholding of new drug application approvals.