# FDA 483 - Atlantis Laboratories, Inc - June 26, 2025

Source: https://www.keypedia.com/records/483/atlantis-laboratories-inc/4aa709f1-0cfd-430e-815d-7dc90005331f

> FDA 483 for Atlantis Laboratories, Inc on June 26, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Atlantis Laboratories, Inc
- Inspection Date: 2025-06-26
- Product Type: drugs
- Office Name: Dallas District Office
- Summary: Atlantis Laboratories, Inc. in Conroe, TX, a contract manufacturer of OTC drugs and cosmetics, received a Form 483 with four observations. The inspection revealed significant deficiencies in the firm's quality control unit, including a lack of written procedures for change control, cleaning validation, and annual product reviews. Additionally, issues were noted with component testing, reserve sample examination, and the identification of container closures.

## Related Officers

- [Oluwasefunmi Agbanigo](https://www.keypedia.com/people/oluwasefunmi-agbanigo/096acae0-9835-4ff1-8faa-c5ec6f551b21)

Company: https://www.keypedia.com/companies/atlantis-laboratories-inc/82749b53-b831-46d0-9994-f8f87ccd6f41

Office: https://www.keypedia.com/offices/dallas-district-office/2d1ee9ae-c44c-4494-8186-a920a69b98f9