# FDA 483 - New Spirit Naturals Inc. - August 24, 2021

Source: https://www.globalkeysolutions.net/records/483/new-spirit-naturals-inc/b74e9653-bbc9-495a-add0-d7441d939667

> FDA 483 for New Spirit Naturals Inc. on August 24, 2021. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: New Spirit Naturals Inc.
- Inspection Date: 2021-08-24
- Product Type: other
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: New Spirit Naturals Inc. in San Dimas, CA, a dietary supplement and juice manufacturer, received a Form 483 with five observations. The inspection revealed significant deficiencies in establishing product specifications for dietary supplements, controlling for contaminants, and maintaining complete batch production records. Additionally, the firm's hazard analysis and HACCP plan for juice products were found to be inadequate, lacking proper identification of hazards and control measures for pathogen reduction.

## Related Documents

- [WARNING_LETTER - 2020-05-07](https://www.globalkeysolutions.net/records/warning_letter/new-spirit-naturals-inc/32efb642-f126-414b-8a6a-bc7a80abbfbe)

## Related Officers

- [Investigator ](https://www.globalkeysolutions.net/people/celena-ngo/bb779423-286c-4342-b1ea-67cc1c44fbd4)

Company: https://www.globalkeysolutions.net/companies/new-spirit-naturals-inc/eb2772b5-96e3-4228-a655-01920dac8ad2

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