FDA 483 - Tianjin Central Pharmaceutical Co., Ltd. - December 17, 2021

Tianjin Central Pharmaceutical Co., Ltd. received a Form 483 for significant deficiencies in its dietary supplement manufacturing processes. The inspection revealed a lack of process validation for sterilization steps, inadequate record-keeping for critical parameters, and unsanitary conditions with unidentifiable material found on supposedly cleaned equipment surfaces. These issues indicate a failure to ensure the quality and safety of dietary supplements, including those exported to the USA.