Drugs

CGMP Violations at Thailand’s S&J International

A 7/17-7/23/2023 FDA inspection at the S&J International Enterprises Public Company Limited drug manufacturing facility in Si Rachi, Thailand, found significant violations of current good manufacturing practice (CGMP) regulations for finished drugs. A 1/26 Warning Letter says specific violations were:

failure of the quality control unit to exercise its responsibility to ensure drug products manufactured comply with CGMP and meet established specifications for identity, strength, quality, and purity; and
failing to prepare batch production and control records with complete information relating to the production and control of each batch of drug product produced.

The letter says that during the inspection S&J delayed or limited access to or copying of requested records, leading to its manufactured drugs being considered adulterated.

FDA says the firm’s quality system does not adequately ensure the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs it manufactures. It recommends that the company engage a qualified consultant to assist it in remediation. The agency also recommends the firm retain a consultant to evaluate its operations and assist it in meeting CGMP requirements.

S&J was placed on an Import Alert on 1/23.

The company was told to correct violations promptly 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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