# FDA 483 - Ozona Organics LLC - December 16, 2021

Source: https://www.globalkeysolutions.net/records/483/ozona-organics-llc/9ce9c6c3-26b8-4eba-aab6-ee21f506c63e

> FDA 483 for Ozona Organics LLC on December 16, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Ozona Organics LLC
- Inspection Date: 2021-12-16
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West III
- Summary: Ozona Organics LLC in Ozona, TX, received a Form 483 with 12 observations highlighting significant deficiencies in their manufacturing practices for both dietary supplements and animal food. The firm lacked essential written procedures for quality control, master manufacturing records, batch production records, and product specifications. Additionally, issues were noted regarding facility design, equipment sanitation, and microbiological control, indicating potential risks of product adulteration.

## Related Officers

- [Research Specialist II](https://www.globalkeysolutions.net/people/justin-a-boyd/796c9c9d-02db-486c-bdca-cc259066a0e2)
- [Florecia S. Philogene](https://www.globalkeysolutions.net/people/florecia-s-philogene/8b77d474-0ae2-40df-860b-e964256c6f5d)

Company: https://www.globalkeysolutions.net/companies/ozona-organics-llc/583acd8e-c5af-4832-8740-55c8f05a4bbb

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-west-iii/2cda09a5-06c4-433f-9df0-0d7903a6efab