# FDA 483 - Elemental Herbs, Inc. - December 20, 2024

Source: https://www.globalkeysolutions.net/records/483/elemental-herbs-inc/ad94e2dd-e1f1-4b87-b371-1e2758e7a174

> FDA 483 for Elemental Herbs, Inc. on December 20, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Elemental Herbs, Inc.
- Inspection Date: 2024-12-20
- Product Type: drugs
- Office Name: Los Angeles District Office
- Summary: Elemental Herbs, Inc. in Morro Bay, CA, a private label distributor of OTC drug products, was cited for significant deficiencies during an FDA inspection. The firm failed to establish an adequate quality control unit, neglected to investigate drug complaints, and lacked proper employee training in current good manufacturing practices. These issues indicate a severe lack of oversight in the manufacturing and quality assurance of their drug products.

## Related Documents

- [483 - 2023-02-03](https://www.globalkeysolutions.net/records/483/elemental-herbs-inc/3e9cbbcc-c788-4298-a0c3-f89c82162ff4)

## Related Officers

- [Consumer Safety Officer](https://www.globalkeysolutions.net/people/sangeeta-m-khurana/bed4533f-a9aa-47c5-9e0b-f20ad36461aa)

Company: https://www.globalkeysolutions.net/companies/elemental-herbs-inc/890bf933-35cd-471c-91e7-bd340b1d0812

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