# FDA 483 - Brio Pharmaceuticals Inc - January 24, 2020

Source: https://www.globalkeysolutions.net/records/483/brio-pharmaceuticals-inc/8a324c13-c0cb-47bb-9009-6c5849d9d466

> FDA 483 for Brio Pharmaceuticals Inc on January 24, 2020. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Brio Pharmaceuticals Inc
- Inspection Date: 2020-01-24
- Product Type: drugs
- Office Name: Dallas District Office
- Summary: An FDA inspection of Woodfield Pharmaceutical, LLC in Houston, TX, revealed significant deficiencies within its quality control unit. The firm failed to adequately implement procedures for investigating out-of-specification environmental monitoring results, including the presence of gram-negative organisms. Additionally, the company did not properly follow its temperature and humidity monitoring program for manufacturing rooms, failing to document temperature excursions.

## Related Documents

- [483 - 2019-07-11](https://www.globalkeysolutions.net/records/483/brio-pharmaceuticals-inc/d9ede2da-3c47-4177-bc0f-09199aee50e6)

## Related Officers

- [Microbiologist](https://www.globalkeysolutions.net/people/camerson-e-moore/50733244-0d55-4b0b-a758-f192b7c66457)

Company: https://www.globalkeysolutions.net/companies/brio-pharmaceuticals-inc/7de121f3-b46f-42fb-90c0-ee912764ab9b

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