# FDA 483 - Belleview 402 LLC - August 20, 2021

Source: https://www.globalkeysolutions.net/records/483/belleview-402-llc/b5689920-0c6a-4f95-84d9-baaf4974de42

> FDA 483 for Belleview 402 LLC on August 20, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Belleview 402 LLC
- Inspection Date: 2021-08-20
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: TG United Inc, an OTC drug manufacturer in Brooksville, FL, was cited for significant deficiencies across its quality system, laboratory controls, and facilities and equipment. The inspection revealed a pervasive lack of cGMP implementation, inadequate quality oversight, and unvalidated test methods, leading to the release of unverified drug products. Repeated observations from previous inspections indicate a systemic failure to address critical compliance issues, particularly concerning water systems and cleaning validations.

## Related Documents

- [483 - 2019-02-15](https://www.globalkeysolutions.net/records/483/belleview-402-llc/bd20fdf2-065e-4116-b53a-6e2b0d8255c5)
- [483 - 2024-03-15](https://www.globalkeysolutions.net/records/483/belleview-402-llc/d3a350bd-3485-4351-806d-4b51a015b650)

## Related Officers

- [Nakesha J Jackson](https://www.globalkeysolutions.net/people/nakesha-j-jackson/7ff47efe-9786-4296-b8c3-6fb5a25b805e)
- [Drug Specialist  / Drug Investigator](https://www.globalkeysolutions.net/people/saundrea-a-munroe/129a869f-e1f2-4d59-b3ed-9613a9190f8a)

Company: https://www.globalkeysolutions.net/companies/belleview-402-llc/e9d8f3d0-3a79-462c-83a1-1e4bb09b4a9c

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