FDA Policy/General

Taizhou Jingshang Cosmetics CGMP Issues

An FDA 11/18-11/21/2024 inspection at the Taizhou Jingshang Cosmetics Technology Co. drug manufacturing facility in Taizhou, Zhejiang Province, China, identified significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A just-released 4/3 Warning Letter says the specific violations were:

failure to conduct at least one test to verify the identity of each component of a drug product and failure to validate and establish the reliability of a component supplier’s test analyses at appropriate intervals;
failure to ensure that laboratory records include complete data derived from all tests necessary to ensure compliance with established specifications and standards; 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 it did not receive a company response stating the specific actions it was taking to address the deficiencies identified on a form FDA-483. It acknowledges the company’s commitment to cease production of all drugs at this facility and says it must notify the agency if it plans to resume drug production.

The agency recommends that Taizhou retain a qualified consultant to evaluate its operations and assist it in meeting CGMP requirements. It notes that some of the firm’s products may be regulated as cosmetics that must comply with applicable statutory and regulatory requirements.

Taizhou was told to promptly correct the violations and to respond with a list of specific actions it has taken to correct the violations and prevent their recurrence, with a schedule for completing the corrections.

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