# FDA 483 - ZECO, LLC - July 19, 2024

Source: https://www.keypedia.com/records/483/zeco-llc/70aa44f2-0f34-466d-909e-ea21808a7660

> FDA 483 for ZECO, LLC on July 19, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: ZECO, LLC
- Inspection Date: 2024-07-19
- Product Type: drugs
- Office Name: New Orleans District Office
- Summary: Zeco LLC, an OTC drug manufacturer in Chattanooga, TN, was cited for significant deficiencies across its quality control, materials, laboratory, and facilities systems. The inspection revealed a pervasive lack of written procedures, inadequate testing, and insufficient validation and control over manufacturing processes and components, indicating a fundamental failure to adhere to current Good Manufacturing Practices.

## Related Officers

- [Gretchen M. Laws](https://www.keypedia.com/people/gretchen-m-laws/9a3ecebd-099b-41d5-a2a7-70811a26cae1)
- [Program Coordinator](https://www.keypedia.com/people/martrice-a-packer/e9d89635-6323-4dc7-9222-c44cedcf46c2)

Company: https://www.keypedia.com/companies/zeco-llc/bca929a5-98de-4be2-8cbd-98471eeaa84c

Office: https://www.keypedia.com/offices/new-orleans-district-office/95352142-b992-4e06-849d-d7483c0959ea