S & J INTERNATIONAL ENTERPRISES PUBLIC COMPANY LIMITED – FDA Warning Letter, Jul 21, 2023

The FDA issued a Warning Letter to S & J International Enterprises Public Company Limited following a July 17-21, 2023, inspection of their drug manufacturing facility in Thailand. The inspection revealed significant Current Good Manufacturing Practice (CGMP) violations, rendering their drug products adulterated under 21 U.S.C. 351(a)(2)(B).

Key violations include: 1. **Quality Control Unit Failure (21 CFR 211.22):** The Quality Unit (QU) failed to ensure CGMP compliance, lacking adequate oversight to prevent production record alteration, ensure complete laboratory documentation, and review raw analytical data. Examples include production staff altering master batch records, undocumented laboratory sample preparation, and the QU only reviewing entered analytical results, not raw data. 2. **Incomplete Batch Production and Control Records (21 CFR 211.188):** Production data was recorded on erasable laminated sheets, which could be altered or lost. Permanent versions of these records were unavailable, and only production staff, not the QU, had access to scanned versions.

The firm also delayed or limited access to requested records during the inspection, leading to drug products being deemed adulterated under 21 U.S.C. 351(j). The FDA found the firm's response to the Form FDA 483 inadequate.

Required corrective actions include a comprehensive assessment and remediation