# FDA 483 - Natren, Inc. - October 08, 2019

Source: https://www.keypedia.com/records/483/natren-inc/c4dacbd8-5510-46d9-94eb-00088221a68c

> FDA 483 for Natren, Inc. on October 08, 2019. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Natren, Inc.
- Inspection Date: 2019-10-08
- Product Type: other
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: Natren, Inc., a manufacturer of probiotic and other products in Thousand Oaks, CA, was inspected by the FDA. The inspection revealed significant issues with laboratory control documentation, including a lack of real-time record-keeping and unreviewed data transfers. Additionally, the firm failed to investigate and justify temperature excursions in its packaging room, leading to potential quality concerns for its products.

## Related Documents

- [483 - 2023-11-02](https://www.keypedia.com/records/483/natren-inc/f982f1c7-0e73-405d-8f17-ac20111cd61c)

## Related Officers

- [Consumer Safety Officer, Drug Specialist](https://www.keypedia.com/people/taichun-qin/62349336-96d6-4452-9c20-9084204b86bf)

Company: https://www.keypedia.com/companies/natren-inc/833a014a-a059-4d52-99e9-e07df60658a8

Office: https://www.keypedia.com/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6