# FDA 483 - Winder Laboratories, LLC - July 18, 2018

Source: https://www.globalkeysolutions.net/records/483/winder-laboratories-llc/8536549e-66fd-40d6-8610-f6506e54057b

> FDA 483 for Winder Laboratories, LLC on July 18, 2018. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Winder Laboratories, LLC
- Inspection Date: 2018-07-18
- Product Type: drugs
- Office Name: Atlanta District Office
- Summary: Winder Laboratories, LLC received a Form 483 citing significant deficiencies across its quality unit, laboratory controls, and manufacturing operations. Key issues include inadequate OOS/OOT investigations, poor data integrity practices, uncalibrated equipment, and unsanitary conditions with pest infestations. These findings indicate a systemic failure to adhere to cGMP requirements, potentially impacting drug product quality and purity.

## Related Documents

- [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)
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- [483 - 2025-08-05](https://www.globalkeysolutions.net/records/483/winder-laboratories-llc/fc784622-93a0-49c4-ae0c-d3ac8a9882cd)
- [WARNING_LETTER - 2025-08-05](https://www.globalkeysolutions.net/records/warning_letter/winder-laboratories-llc/ad509dd1-ddde-4d24-a4c5-b2f7bd08e6e7)

## Related Officers

- [Johnetta F. Walters](https://www.globalkeysolutions.net/people/johnetta-f-walters/61bdf49d-888c-4a02-976f-5cb00aff0fa9)
- [Pratik S. Upadhyay](https://www.globalkeysolutions.net/people/pratik-s-upadhyay/22ff2e0b-17d4-4c91-a3f0-c7e30b7a115b)

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