Drugs

CGMP Violations at China’s Shantou S.E.Z. Baojie

A 4/26-4/30/2024 FDA inspection at Shantou S.E.Z. Bajoie Industry Co., Ltd., in Shantou, Guangdong, China, identified significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A just-released 4/15 Warning Letter says the specific violations were:

failure to test samples of each component for identity and conformity with all appropriate written specifications for purity, strength, and quality, and failure to validate and establish the reliability of the component supplier’s test analyses at appropriate intervals;
failure to establish adequate written procedures for production and process control designed to assure that manufactured drug products have the identity, strength, quality, and purity they purport or are represented to possess;
failure to establish and follow an adequate written testing program designed to assess the stability characteristics of drug products and to use results of stability testing to determine appropriate storage conditions and expiration dates; and
failure of the firm’s quality control unit to exercise its responsibility to ensure that manufactured drug products comply with CGMP and meet established specifications for identity, strength, quality, and purity.

FDA says the firm’s responses to the inspection observations were inadequate. It recommends that Shantou engage a qualified consultant to evaluate its operations and assist it in meeting CGMP requirements. The agency also notes that some of the products the firm manufactures may be regulated as cosmetics that must comply with applicable laws and regulations.

Shantou’s products were placed on a 4/9 Import Alert. The company was told to correct any violations promptly and to respond with a list of specific actions it has taken to address the violations and prevent their recurrence, with a schedule for completing the corrections.

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Gupta Raises Concerns About Overton’s Independence, Ideology

Overton Confirmation Remains Uncertain After Senate Hearing

FDA Classifies Boston Scientific Imager II Catheter Recall as Class I

FDA Approves Gazyva for Childhood-Onset Idiopathic Nephrotic Syndrome