# FDA 483 - BELOTECA INC - August 29, 2025

Source: https://www.keypedia.com/records/483/beloteca-inc/3f7edcfc-de99-4da5-baf0-d1cf794b06e9

> FDA 483 for BELOTECA INC on August 29, 2025. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: BELOTECA INC
- Inspection Date: 2025-08-29
- Product Type: drugs
- Office Name: Los Angeles District Office
- Summary: BELOTECA INC in San Diego, CA, was inspected from August 25-29, 2025, and received a Form 483 with three observations. The inspection revealed significant deficiencies in post-marketing surveillance, including a lack of written procedures for adverse drug experiences and the late submission of multiple periodic adverse drug experience reports and annual reports for their combination products. These issues indicate a failure to comply with regulatory reporting requirements.

## Related Officers

- [Linh Tu](https://www.keypedia.com/people/linh-tu/142c94dc-9538-4c52-9a5f-be27fc7c4f4b)
- [Lan T. Tran](https://www.keypedia.com/people/lan-t-tran/ab9c1008-c03f-425f-ac3c-a569d3e5037c)

Company: https://www.keypedia.com/companies/beloteca-inc/093a8acc-fd1a-48f5-b386-bf448aa5c675

Office: https://www.keypedia.com/offices/los-angeles-district-office/edcf1dfe-596a-43b8-8df4-07d9cd94763b