# FDA 483 - Seven - April 08, 2021

Source: https://www.keypedia.com/records/483/seven/4c1d9c40-585c-452e-beab-ed8b124b278c

> FDA 483 for Seven on April 08, 2021. Product: other. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Seven
- Inspection Date: 2021-04-08
- Product Type: other
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: Seven, a contract manufacturer of dietary supplements in Vista, CA, was cited for numerous significant quality control and documentation deficiencies during an FDA inspection. The firm failed to establish and adhere to specifications for components, finished products, and packaging, and lacked proper quality control oversight for material review, batch records, and master manufacturing records. Several observations were noted as repeat violations, indicating persistent issues with their manufacturing processes.

## Related Documents

- [WARNING_LETTER - 2019-08-19](https://www.keypedia.com/records/warning_letter/seven/af378d60-78dc-48ca-8f7e-59bb6a298848)

## Related Officers

- [Natalie J. Reese](https://www.keypedia.com/people/natalie-j-reese/905b99fa-9b8a-47a6-a73a-fe532651c0ae)
- [Elizabeth C. Ajuzie](https://www.keypedia.com/people/elizabeth-c-ajuzie/d89a9e17-4e7c-4995-a090-b0bf7add549d)

Company: https://www.keypedia.com/companies/seven/08496492-9322-43d8-80b4-b352006f097e

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