# FDA 483 - SCI Pharmtech Inc. - June 06, 2025

Source: https://www.globalkeysolutions.net/records/483/sci-pharmtech-inc/ad8a9849-6618-43b2-ada7-5addfaf165da

> FDA 483 for SCI Pharmtech Inc. on June 06, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: SCI Pharmtech Inc.
- Inspection Date: 2025-06-06
- Product Type: drugs
- Office Name: Office of Inspections and Investigations
- Summary: An FDA inspection of SCI Pharmtech Inc., an API manufacturer in Taoyuan City, Taiwan, revealed a significant issue with batch production records. The firm's records failed to include representative labels for APIs or commercially produced intermediates, indicating a deficiency in documentation practices. This observation highlights a concern regarding the completeness and accuracy of manufacturing records.

## Related Officers

- [Nicholas J. Presto](https://www.globalkeysolutions.net/people/nicholas-j-presto/2ecdd573-6662-4d07-b93c-ddb9c603bcfa)

Company: https://www.globalkeysolutions.net/companies/sci-pharmtech-inc/38edf740-19b5-4fbf-bd65-e8cd87a7b1db

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