# FDA 483 - Austin Biotechnology Inc. - May 29, 2015

Source: https://www.keypedia.com/records/483/austin-biotechnology-inc/f9c03c1a-ccdf-45a0-ab95-c51ed45bc97a

> FDA 483 for Austin Biotechnology Inc. on May 29, 2015. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Austin Biotechnology Inc.
- Inspection Date: 2015-05-29
- Product Type: drugs
- Office Name: Division of Clinical Evidence and Analysis 1 (Clinical Policy and Quality)
- Summary: Austin Biotechnology Inc. in Taipei, Taiwan, a drug manufacturer, was cited with ten observations during an FDA inspection. The inspection revealed significant deficiencies across its quality system, including the absence of a quality control unit, inadequate production and stability records, and issues with product labeling and testing. These findings indicate a severe lack of adherence to good manufacturing practices for drug products.

## Related Officers

- [Heriberto Negron Rivera](https://www.keypedia.com/people/heriberto-negron-rivera/48d7f4d3-53bd-4c8e-903b-37cca60d4970)

Company: https://www.keypedia.com/companies/austin-biotechnology-inc/d6d29ef5-a904-4dba-99a7-9b2ee6c5a2a2

Office: https://www.keypedia.com/offices/division-of-clinical-evidence-and-analysis-1-clinical-policy-and-quality/5f95da17-30bb-423f-b892-5ea041823fbd