# FDA 483 - SBH Medical, LTD - September 30, 2019

Source: https://www.keypedia.com/records/483/sbh-medical-ltd/5d7c89f8-44b9-486f-bd3b-75a130f556d9

> FDA 483 for SBH Medical, LTD on September 30, 2019. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: SBH Medical, LTD
- Inspection Date: 2019-09-30
- Product Type: Drugs
- Office Name: Cincinnati District Office
- Summary: An FDA inspection of SBH Medical LTD., a producer of sterile and non-sterile drugs located in Worthington, OH, was conducted on multiple dates throughout September 2019, concluding with the issuance of a Form FDA 483 on September 30, 2019. The inspection identified a critical observation concerning the company's aseptic production operations, indicating a potential deviation from regulatory expectations for Good Manufacturing Practices.

The main issue, identified as Observation 1, stated that media fills were not performed to accurately simulate aseptic production operations, particularly those involving worst-case activities and conditions that challenge aseptic processes. Specifically, the firm lacked media fills for <Redacted B4>, which represents the most complex and manipulative conditions within their operations. Media fills are crucial for validating aseptic techniques and ensuring product sterility.

This observation signals a need for SBH Medical LTD. to enhance its validation protocols for aseptic processing. The regulatory framework implied by the FDA 483 requires the company to address these inspectional findings. SBH Medical LTD. is expected to respond to the FDA, outlining comprehensive corrective and preventive actions to resolve the identified deficiency, ensuring compliance with sterile manufacturing standards and safeguarding product quality.

## Related Officers

- [Ucheabuchi C. Chudi-nwankwor](https://www.keypedia.com/people/ucheabuchi-c-chudi-nwankwor/18b01d08-3cfd-4ace-97b2-5f54b6427661)
- [Investigator](https://www.keypedia.com/people/andrew-baiwwcliff/469ed658-10fe-435e-9931-9ccbbd148ab4)
- [Andrew J. Barrowcliff](https://www.keypedia.com/people/andrew-j-barrowcliff/5dd49407-9028-4c84-9e86-3f0b6239538e)
- [CSO](https://www.keypedia.com/people/chudi-nwankwor/6893099e-45c4-488d-99db-a16dc4832116)

Company: https://www.keypedia.com/companies/sbh-medical-ltd/e63d139c-b48d-464d-aec7-4852952176a4

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