# FDA 483 - Balassa Laboratories, Inc. - April 07, 2023

Source: https://www.globalkeysolutions.net/records/483/balassa-laboratories-inc/a343a2ae-99b2-4e89-81e9-6dcd1ab8a1a5

> FDA 483 for Balassa Laboratories, Inc. on April 07, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Balassa Laboratories, Inc.
- Inspection Date: 2023-04-07
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: An FDA inspection of Balassa Laboratories, Inc. in Port Orange, FL, an OTC drug manufacturer, revealed three significant observations related to current Good Manufacturing Practices. Issues included inadequate handling and storage of components leading to potential cross-contamination, missing execution results for equipment installation and operational qualifications, and a failure to properly identify the status of major manufacturing equipment.

## Related Officers

- [issuing_officer](https://www.globalkeysolutions.net/people/harshal-j-desai/9ccefb1f-95fc-4a17-9647-eecb5c3ce838)

Company: https://www.globalkeysolutions.net/companies/balassa-laboratories-inc/86332abb-f7b6-407f-a65e-3c0ecf3c16fd

Office: https://www.globalkeysolutions.net/offices/office-of-medical-device-and-radiological-health-division-ii/ae9bd439-479a-420d-9dd8-9fe1fc0863d6