# FDA 483 - S & J INTERNATIONAL ENTERPRISES PUBLIC COMPANY LIMITED - July 21, 2023

Source: https://www.keypedia.com/records/483/s-j-international-enterprises-public-company-limited/b18d44b8-6594-4414-bf2b-0df0a500bc6c

> FDA 483 for S & J INTERNATIONAL ENTERPRISES PUBLIC COMPANY LIMITED on July 21, 2023. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: S & J INTERNATIONAL ENTERPRISES PUBLIC COMPANY LIMITED
- Inspection Date: 2023-07-21
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: An FDA inspection of S & J INTERNATIONAL ENTERPRISES PUBLIC COMPANY LIMITED in Si Racha, Thailand, a manufacturer, revealed significant deficiencies in laboratory control systems and quality control unit responsibilities. Observations included failures to maintain complete records for laboratory reference standards and test calculations, as well as a lack of proper written procedures and authority for the quality control unit, leading to concerns about data integrity and batch record control.

## Related Documents

- [WARNING_LETTER - 2023-07-21](https://www.keypedia.com/records/warning_letter/s-j-international-enterprises-public-company-limited/6d887f0a-f874-46ac-a2c9-c0b67143bf44)

## Related Officers

- [James R. Birkenstamm](https://www.keypedia.com/people/james-r-birkenstamm/eb1192a4-3c76-4243-886c-9b5805871ad1)

Company: https://www.keypedia.com/companies/s-j-international-enterprises-public-company-limited/eb1edde7-31bd-4deb-9874-31d81bdedddb

Office: https://www.keypedia.com/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1