# FDA 483 - Betco Corporation, Ltd - April 17, 2025

Source: https://www.globalkeysolutions.net/records/483/betco-corporation-ltd/0ab81ae4-36ad-4809-a1f3-3aac74da7c85

> FDA 483 for Betco Corporation, Ltd on April 17, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Betco Corporation, Ltd
- Inspection Date: 2025-04-17
- Product Type: drugs
- Office Name: Cincinnati District Office
- Summary: The FDA inspected Betco Corporation, Ltd in Bowling Green, OH, an OTC drug manufacturer, and issued a Form 483 with four observations. The inspection revealed significant deficiencies in component identity testing, inadequate water system qualification and maintenance, and insufficient laboratory sampling plans for water. Additionally, the quality control unit lacked written procedures for Out-of-Specification (OOS) investigations, leading to untracked instances.

## Related Officers

- [Anna M. Spiros](https://www.globalkeysolutions.net/people/anna-m-spiros/13e6a69c-d3d5-431c-9895-0df9b86691b7)
- [WenNing Chan](https://www.globalkeysolutions.net/people/wenning-chan/973bf578-405d-46cf-b09e-254d6db07c08)
- [Mathematical statistician](https://www.globalkeysolutions.net/people/wen-ning-chan/e1f71810-6994-4474-876f-699ea9dee32c)

Company: https://www.globalkeysolutions.net/companies/betco-corporation-ltd/ed38f858-e0ae-4acd-9ecf-9d8542c4f98d

Office: https://www.globalkeysolutions.net/offices/cincinnati-district-office/b67a0c35-82e3-4176-9039-988378f65c22