# FDA 483 - PREMIER NUTRA PHARMA Inc. - July 08, 2022

Source: https://www.keypedia.com/records/483/premier-nutra-pharma-inc/d6436604-4f64-4382-9093-45bdef639ed6

> FDA 483 for PREMIER NUTRA PHARMA Inc. on July 08, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: PREMIER NUTRA PHARMA Inc.
- Inspection Date: 2022-07-08
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: PREMIER NUTRA PHARMA Inc. in Carlsbad, CA, a drug manufacturer, was inspected and found to have significant deficiencies across its quality control, manufacturing processes, and facility maintenance. Key issues include releasing contaminated products without proper testing, lacking essential batch records and quality unit oversight, and maintaining unsanitary conditions. These conditions pose a public health risk due to potential product contamination.

## Related Documents

- [WARNING_LETTER - 2019-03-19](https://www.keypedia.com/records/warning_letter/premier-nutra-pharma-inc/40e0ef1a-1d55-4fc0-a35f-ef47bedda39f)
- [483 - 2022-07-08](https://www.keypedia.com/records/483/premier-nutra-pharma-inc/4de00fa4-e196-4ec3-b573-e084b79507b2)
- [WARNING_LETTER - 2022-07-08](https://www.keypedia.com/records/warning_letter/premier-nutra-pharma-inc/3af700d4-bd42-4022-a662-33ff835bcc44)

## Related Officers

- [Rachel C. Stanton](https://www.keypedia.com/people/rachel-c-stanton/36495725-366c-4138-a4d8-df3ce38fa9cd)
- [Investigator](https://www.keypedia.com/people/roger-f-zabinski/87e05838-f8b5-489a-8db7-6669e68a2c2e)

Company: https://www.keypedia.com/companies/premier-nutra-pharma-inc/11855ceb-ab2f-4a9b-a5bd-bc304434c5ae

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