# FDA 483 - Winder Laboratories, LLC - March 13, 2020

Source: https://www.keypedia.com/records/483/winder-laboratories-llc/e0765000-d7cf-4e55-815f-12e5625579b3

> FDA 483 for Winder Laboratories, LLC on March 13, 2020. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Winder Laboratories, LLC
- Inspection Date: 2020-03-13
- Product Type: drugs
- Office Name: Atlanta District Office
- Summary: Winder Laboratories, LLC, a drug manufacturer in Winder, GA, was cited for significant deficiencies during an FDA inspection from March 9-13, 2020. Observations included inadequate design and control of the purified water system, failure to microbiologically test components, insufficient investigations into water failures and out-of-specification results, and deficient complaint handling. These issues indicate a lack of robust quality control and investigation processes.

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## 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