# FDA 483 - ABS Corporation - August 11, 2023

Source: https://www.globalkeysolutions.net/records/483/abs-corporation/1916e3d0-c563-4329-9b34-e8720a35f498

> FDA 483 for ABS Corporation on August 11, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: ABS Corporation
- Inspection Date: 2023-08-11
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West II
- Summary: ABS Corporation, a contract manufacturer in Omaha, NE, was cited for significant deficiencies in its quality system during an FDA inspection. The firm failed to adequately investigate out-of-specification results, lacked proper validation for production and cleaning processes, and exhibited poor data integrity controls over its laboratory computer systems. Additionally, the quality control unit's responsibilities were not fully documented, including the absence of critical quality agreements with customers.

## Related Documents

- [483 - 2023-08-11](https://www.globalkeysolutions.net/records/483/abs-corporation/0c623efe-ec90-49e7-a9b8-929266a0b234)

## Related Officers

- [Torrey M. Ward](https://www.globalkeysolutions.net/people/torrey-m-ward/e3021951-811e-45a0-a029-69c7cc862fcf)

Company: https://www.globalkeysolutions.net/companies/abs-corporation/27a5f4ae-a47d-4f3a-9861-a43b9e26df57

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-west-ii/8851d151-0390-4d17-be66-fd86d12aa6b8