# FDA 483 - SMS Pharmaceutical Limited - Unit VII - December 12, 2025

Source: https://www.keypedia.com/records/483/sms-pharmaceutical-limited-unit-vii/8d088dee-6b5a-48cc-9ba6-e05a3ff200c6

> FDA 483 for SMS Pharmaceutical Limited - Unit VII on December 12, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: SMS Pharmaceutical Limited - Unit VII
- Inspection Date: 2025-12-12
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: SMS Pharmaceuticals Limited, Unit-VII, an API manufacturer, was cited for failing to ensure that specifications for Active Pharmaceutical Ingredients (API) are scientifically sound and appropriate. Specifically, the firm did not follow its established criteria for extraneous matter testing, leading to a batch with failing results being incorrectly reported as passing and subsequently dispatched to the US market.

## Related Documents

- [483 - 2020-01-17](https://www.keypedia.com/records/483/sms-pharmaceutical-limited-unit-vii/bed084bf-f3ef-4526-ac39-42dbdf4ac7a7)

## Related Officers

- [Rowena S. Nguyen](https://www.keypedia.com/people/rowena-s-nguyen/ae39318e-1653-467c-94cc-26f8929441ac)

Company: https://www.keypedia.com/companies/sms-pharmaceutical-limited-unit-vii/6e603404-91dc-46e3-ace7-5e9fc5941538

Office: https://www.keypedia.com/offices/office-of-inspections-and-investigations/7dd0b904-a3df-46bc-a7b2-70ddb6f809c8