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

Source: https://www.keypedia.com/records/483/winder-laboratories-llc/bf7d3ac4-d454-4986-949d-a58394a196a9

> 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 inspected and received a Form 483 with four observations. The inspection revealed significant deficiencies primarily related to the firm's purified water system, including inadequate design, control, maintenance, and monitoring, as well as a failure to test for objectionable microorganisms. Additionally, the firm failed to thoroughly investigate unexplained discrepancies, out-of-specification results, and customer complaints for its elixir and tablet products.

## 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/7515c096-2c04-4bdc-bfd5-a3ecc630cc48

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