# FDA 483 - Winder Laboratories, LLC - August 05, 2025

Source: https://www.globalkeysolutions.net/records/483/winder-laboratories-llc/fc784622-93a0-49c4-ae0c-d3ac8a9882cd

> FDA 483 for Winder Laboratories, LLC on August 05, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Winder Laboratories, LLC
- Inspection Date: 2025-08-05
- Product Type: drugs
- Office Name: Atlanta District Office
- Summary: Winder Laboratories, LLC received a Form 483 with numerous significant observations related to its drug manufacturing operations. Key issues include quality control unit failures, premature product release, inadequate stability testing, lack of process validation, and widespread deficiencies in cleaning, equipment maintenance, and documentation practices. These findings indicate a systemic lack of adherence to cGMP regulations, posing potential risks to drug product quality, safety, and efficacy.

## Related Documents

- [483 - 2018-07-18](https://www.globalkeysolutions.net/records/483/winder-laboratories-llc/8536549e-66fd-40d6-8610-f6506e54057b)
- [WARNING_LETTER - 2018-07-18](https://www.globalkeysolutions.net/records/warning_letter/winder-laboratories-llc/b5308ae8-a871-4627-99bf-9cd705a3b2fc)
- [483 - 2020-03-13](https://www.globalkeysolutions.net/records/483/winder-laboratories-llc/e0765000-d7cf-4e55-815f-12e5625579b3)
- [483 - 2023-02-03](https://www.globalkeysolutions.net/records/483/winder-laboratories-llc/29ec53d0-0427-449a-af6d-dc88da5613b7)
- [WARNING_LETTER - 2025-08-05](https://www.globalkeysolutions.net/records/warning_letter/winder-laboratories-llc/ad509dd1-ddde-4d24-a4c5-b2f7bd08e6e7)

## Related Officers

- [Pharmaceutical Specialist/ Investigator ](https://www.globalkeysolutions.net/people/veronica-fuentes/50ea657f-39e6-4d97-a627-86339df3fbe6)
- [Samantha E. Cleek](https://www.globalkeysolutions.net/people/samantha-e-cleek/7305f28f-9c92-427d-86ec-42c0bb6bf3ce)

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

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