# FDA 483 - Romark Global Pharma, LLC - April 27, 2020

Source: https://www.keypedia.com/records/483/romark-global-pharma-llc/3e58583d-d809-4d01-8213-4fef17485fe7

> FDA 483 for Romark Global Pharma, LLC on April 27, 2020. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Romark Global Pharma, LLC
- Inspection Date: 2020-04-27
- Product Type: drugs
- Office Name: Dallas District Office
- Summary: An FDA inspection of Romark Global Pharma, LLC in Manati, PR, revealed significant deficiencies in preventing microbiological contamination in drug products, particularly NT-300 tablets. The firm's procedures for manufacturing, equipment cleaning, and quality control were found to be inadequate, leading to product rejections and a high risk of contamination. These issues indicate a systemic failure in maintaining a state of control over microbial quality.

## Related Officers

- [Libia Lugo](https://www.keypedia.com/people/libia-lugo/55f1387e-b6bd-41ca-8507-45829629dac5)

Company: https://www.keypedia.com/companies/romark-global-pharma-llc/cafe2d14-e123-4e95-ae78-eb1c29e5adc3

Office: https://www.keypedia.com/offices/dallas-district-office/2d1ee9ae-c44c-4494-8186-a920a69b98f9