# FDA 483 - Winder Laboratories, LLC - February 03, 2023

Source: https://www.keypedia.com/records/483/winder-laboratories-llc/29ec53d0-0427-449a-af6d-dc88da5613b7

> FDA 483 for Winder Laboratories, LLC on February 03, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Winder Laboratories, LLC
- Inspection Date: 2023-02-03
- Product Type: drugs
- Office Name: Atlanta District Office
- Summary: Winder Laboratories, LLC, a drug manufacturer in Winder, GA, received an FDA Form 483 citing significant deficiencies. The inspection revealed inadequate computer system controls and data integrity issues, including a lack of audit trail review and proper project folder management. Additionally, the firm failed to establish appropriate laboratory controls for elemental impurities and lacked sufficient written procedures for component testing and quality unit responsibilities.

## Related Documents

- [483 - 2018-07-18](https://www.keypedia.com/records/483/winder-laboratories-llc/8536549e-66fd-40d6-8610-f6506e54057b)
- [WARNING_LETTER - 2018-07-18](https://www.keypedia.com/records/warning_letter/winder-laboratories-llc/b5308ae8-a871-4627-99bf-9cd705a3b2fc)
- [483 - 2020-03-13](https://www.keypedia.com/records/483/winder-laboratories-llc/e0765000-d7cf-4e55-815f-12e5625579b3)
- [483 - 2025-08-05](https://www.keypedia.com/records/483/winder-laboratories-llc/fc784622-93a0-49c4-ae0c-d3ac8a9882cd)
- [WARNING_LETTER - 2025-08-05](https://www.keypedia.com/records/warning_letter/winder-laboratories-llc/ad509dd1-ddde-4d24-a4c5-b2f7bd08e6e7)

## Related Officers

- [Susan O. Oladeji](https://www.keypedia.com/people/susan-o-oladeji/307277f8-7704-4ada-8d8d-d77118c6cb77)

Company: https://www.keypedia.com/companies/winder-laboratories-llc/f4e61e0c-e35c-48e8-b7a8-56f1e0aada1c

Office: https://www.keypedia.com/offices/atlanta-district-office/7586d99a-288e-49d1-8c3d-d88b7354b7a7