# FDA 483 - Absolutely Natural - April 24, 2025

Source: https://www.keypedia.com/records/483/absolutely-natural/25dbdf95-8935-48dc-8032-84b3ddfa5614

> FDA 483 for Absolutely Natural on April 24, 2025. Product: cosmetics. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Absolutely Natural
- Inspection Date: 2025-04-24
- Product Type: cosmetics
- Office Name: Florida District Office
- Summary: Absolutely Natural, a manufacturer in Melbourne, FL, received a Form 483 following an FDA inspection from April 22-24, 2025. The inspection revealed significant deficiencies in quality control, laboratory practices, and equipment management, particularly concerning water system validation, microbial testing, and cleaning verification for human OTC drug products and cosmetics. Several observations, including issues with test method validation and component identity testing, were repeat findings from a previous inspection in 2019, indicating persistent non-compliance.

## Related Documents

- [483 - 2019-06-14](https://www.keypedia.com/records/483/absolutely-natural/2759c402-7495-493b-aada-ec402216c265)
- [WARNING_LETTER - 2025-04-24](https://www.keypedia.com/records/warning_letter/absolutely-natural/2fd2a80a-462e-4ecb-b86c-abd378c48103)

## Related Officers

- [Pamela N. Agaba](https://www.keypedia.com/people/pamela-n-agaba/1ad981d6-8074-4572-8648-7d35f41e94f6)
- [Damaris Y. Hernandez](https://www.keypedia.com/people/damaris-y-hernandez/ca16093e-047b-4bf1-bcc1-c439cff21e8a)

Company: https://www.keypedia.com/companies/absolutely-natural/cb6a7d5c-99b4-4103-b94c-d93d9c0aa2ba

Office: https://www.keypedia.com/offices/florida-district-office/95b2a118-0b78-46e0-a54c-982bd7ce51c9