# FDA 483 - New Vision Pharmaceuticals LLC - March 23, 2023

Source: https://www.globalkeysolutions.net/records/483/new-vision-pharmaceuticals-llc/a9e9e9b5-acdf-4f6b-b821-d0e0af0d0edc

> FDA 483 for New Vision Pharmaceuticals LLC on March 23, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: New Vision Pharmaceuticals LLC
- Inspection Date: 2023-03-23
- Product Type: drugs
- Office Name: Office of Medical Device and Radiological Health Division II
- Summary: An FDA inspection of New Vision Pharmaceuticals LLC in Tamarac, FL, a sterile drug manufacturer, revealed significant deficiencies across multiple areas. Observations included inadequate procedures for preventing microbiological contamination, insufficient validation of aseptic processes, and a lack of established production and process controls for sterile drug products. Additionally, the firm failed to properly follow quality control unit responsibilities and maintain adequate equipment cleaning procedures.

## Related Documents

- [483 - 2021-10-29](https://www.globalkeysolutions.net/records/483/new-vision-pharmaceuticals-llc/c5a2efb5-f3a7-4403-a4f7-69f776132f0f)

## Related Officers

- [Program Coordinator](https://www.globalkeysolutions.net/people/martrice-a-packer/e9d89635-6323-4dc7-9222-c44cedcf46c2)
- [Seneca D. Toms](https://www.globalkeysolutions.net/people/seneca-d-toms/3eda62a2-4c12-438f-805a-5e3efb0f2f94)
- [Medical Officer at FDA](https://www.globalkeysolutions.net/people/brittny-c-cargo/a3479241-5390-4ddb-b892-df0bac1c89cf)

Company: https://www.globalkeysolutions.net/companies/new-vision-pharmaceuticals-llc/e417abca-4395-4a48-8f03-b7f0752d264b

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