# FDA 483 - Opti Source International - April 04, 2024

Source: https://www.globalkeysolutions.net/records/483/opti-source-international/8aaaf960-9e6f-4fa9-ba4f-1179120ce7a5

> FDA 483 for Opti Source International on April 04, 2024. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Opti Source International
- Inspection Date: 2024-04-04
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: Opti Source International, an OTC drug manufacturer in Bellport, NY, was cited with 11 observations during an FDA inspection. The firm failed to adhere to numerous Current Good Manufacturing Practices, including using expired components, lacking a quality control unit, and failing to perform essential product and component testing. These deficiencies indicate a systemic breakdown in quality assurance for their Optimal Foaming Hand Sanitizer product.

## Related Officers

- [Vivin George](https://www.globalkeysolutions.net/people/vivin-george/0b0ee298-a577-4bee-b18e-42da0c3bb148)

Company: https://www.globalkeysolutions.net/companies/opti-source-international/e2587474-def9-4da2-9e4d-5a8229f54444

Office: https://www.globalkeysolutions.net/offices/division-of-human-and-animal-food-operations-east-i/a807f00e-d780-40b8-b233-1eb92ece8961