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

Source: https://www.keypedia.com/records/483/premier-nutra-pharma-inc/4de00fa4-e196-4ec3-b573-e084b79507b2

> 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: Los Angeles District Office
- Summary: **FDA 483 Summary: Premier Nutra Pharma Inc.**

**Inspection Dates:** July 5-8, 2022  
**Company:** Premier Nutra Pharma Inc.  
**Location:** 5800 Newton Dr, Carlsbad, CA 92008-7311  
**Type of Establishment:** Drug Manufacturer  
**FEI Number:** 3017303868  
**Report Issued To:** Israel Kravzov, Co-CEO  

**Main Violations/Issues:**

1. **Deficient Conformance to Specifications:** The firm released drug products without validated microbiological testing, using contaminated raw materials. Specifically, a product was released before microbiological contamination tests were completed, posing a public health risk.

2. **Inadequate Batch Records:** The firm lacks comprehensive batch production and control records for drug products and supplements. Available records are incomplete and not maintained on-site, relying instead on customer-provided information.

3. **Absence of Quality Control Unit:** The firm does not have an established Quality Control Unit or laboratory. There is no testing of raw materials, finished products, or environmental monitoring, relying solely on customer testing without formal agreements.

**Regulatory Framework:** The observations highlight non-compliance with FDA regulations for drug manufacturing, particularly concerning quality control, batch record maintenance, and product testing.

**Required Actions:**

- Implement validated microbiological testing procedures for all products before release.
- Establish and maintain complete batch production and control records on-site.
- Develop a formal Quality Control Unit with documented responsibilities and procedures.
- Conduct thorough testing of raw materials and finished products, ensuring compliance before market release.
- Formalize Quality Agreements with customers to clearly define testing responsibilities.

These corrective actions are necessary to ensure compliance with FDA regulations and to protect public health.

## 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/d6436604-4f64-4382-9093-45bdef639ed6)
- [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/los-angeles-district-office/edcf1dfe-596a-43b8-8df4-07d9cd94763b