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