# FDA 483 - Ethical Nutritional, LLC dba Remedy Makers - December 05, 2024

Source: https://www.globalkeysolutions.net/records/483/ethical-nutritional-llc-dba-remedy-makers/4cb86035-4263-4f9a-bac8-c0d61548cdc8

> FDA 483 for Ethical Nutritional, LLC dba Remedy Makers on December 05, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Ethical Nutritional, LLC dba Remedy Makers
- Inspection Date: 2024-12-05
- Product Type: drugs
- Office Name: Los Angeles District Office
- Summary: Ethical Nutritional, LLC dba Remedy Makers in Pomona, CA, was cited for significant deficiencies in its manufacturing processes for homeopathic drug products. The inspection revealed a lack of essential written procedures for production and process controls, including validation, cleaning, supplier qualification, and recalls. Additionally, the firm demonstrated inadequate personnel, unqualified equipment, a deficient quality control unit, and a complete absence of stability testing and proper investigation of material failures.

## Related Officers

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

Company: https://www.globalkeysolutions.net/companies/ethical-nutritional-llc-dba-remedy-makers/9e62c4aa-ec05-4c81-8da6-cb2813a25cc6

Office: https://www.globalkeysolutions.net/offices/los-angeles-district-office/edcf1dfe-596a-43b8-8df4-07d9cd94763b