# FDA 483 - ARMINAK SOLUTIONS LLC. - November 03, 2023

Source: https://www.globalkeysolutions.net/records/483/arminak-solutions-llc/e4ba4a7d-70be-4fb5-935e-c8127bab7ede

> FDA 483 for ARMINAK SOLUTIONS LLC. on November 03, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: ARMINAK SOLUTIONS LLC.
- Inspection Date: 2023-11-03
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: Adonis Inc., a manufacturer and repacker in Corona, CA, was cited for multiple significant deficiencies during an FDA inspection. The firm failed to establish adequate production and process controls, including process validation and equipment qualification, and demonstrated poor control over material testing, quality unit responsibilities, and labeling. These issues indicate a lack of adherence to Good Manufacturing Practices, posing risks to drug product quality and safety.

## Related Officers

- [Rowena S. Nguyen](https://www.globalkeysolutions.net/people/rowena-s-nguyen/ae39318e-1653-467c-94cc-26f8929441ac)

Company: https://www.globalkeysolutions.net/companies/arminak-solutions-llc/2f2715c6-a0ab-44a1-bfa7-55fb4865fc82

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