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483
•Chia Tai Tianqing Pharmaceutical Group Co., Ltd.•January 6, 2021

Chia Tai Tianqing Pharmaceutical Group Co., Ltd. – FDA 483, Jan 6, 2021

Record Details

An FDA inspection of Chia Tai Tianqing Pharmaceutical Group Co., Ltd. in Lianyungang, China, revealed deficiencies in the firm's quality control unit. The company failed to ensure that responsibilities and procedures for the quality control unit were adequately documented and followed. Specifically, issues were noted with assessing the effectiveness of corrective and preventive actions (CAPA) and with internal audit procedures.

Company
Chia Tai Tianqing Pharmaceutical Group Co., Ltd.
Inspection date
January 6, 2021
Product type
drugs
Office
Office of Biological Products Operations - Division I
Person
  • Marijo B. Kambere
View Company Profile

ID · 81b2a3d7-5e28-4f1f-8866-6ed6cca0283e

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