S & J International Enterprises Public Company Limited

Warning LetterOpen

Mr. Praj Srichandra Factory Division Manager, Board Member of Saha Group S & J International Enterprises Public Company Limited 600/4 Moo.11 Sukaphiban 8 Road Nongkharm , Si Racha Chon Buri 20230 ThailandFEI 3005979923Issued Jan 26, 2024Center for Drug Evaluation and Research | CDER

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Letter Details

Firm: S & J International Enterprises Public Company Limited
Location: Mr. Praj Srichandra Factory Division Manager, Board Member of Saha Group S & J International Enterprises Public Company Limited 600/4 Moo.11 Sukaphiban 8 Road Nongkharm , Si Racha Chon Buri 20230 Thailand
FEI Number: 3005979923
Country: Thailand
Issue Date: January 26, 2024
Issuing Office: Center for Drug Evaluation and Research | CDER
Product Type: Drugs
Status: Open

Summary

S & J International Enterprises Public Company Limited, a drug manufacturing facility in Thailand, violated Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals during an FDA inspection in July 2023, resulting in adulterated drug products. The company's quality control unit failed to exercise adequate oversight and control over manufacturing operations and did not ensure products met established specifications for identity, strength, quality, and purity. Additionally, the firm delayed or limited FDA inspectors' access to and copying of records during the inspection, further violating the Federal Food, Drug, and Cosmetic Act. The company's response to the FDA's Form 483 observations was deemed inadequate as it lacked sufficient detail and evidence of corrective actions needed to achieve CGMP compliance.

S & J International Enterprises Public Company Limited FDA Warning Letter, January 26, 2024