# FDA 483 - Greenbrier International, Inc - October 05, 2021

Source: https://www.keypedia.com/records/483/greenbrier-international-inc/d3b2217f-721c-418d-8405-53e72b573339

> FDA 483 for Greenbrier International, Inc on October 05, 2021. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Greenbrier International, Inc
- Inspection Date: 2021-10-05
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - East I
- Summary: Greenbrier International, Inc. in Chesapeake, VA, was inspected regarding its corporate office operations. The inspection revealed significant deficiencies in the firm's quality control unit, particularly concerning oversight of contract manufacturing organizations (CMOs) for OTC drug products. The firm lacked adequate written procedures for quality assurance, complaint handling, and employee training, indicating a systemic failure to ensure product quality and compliance with CGMP requirements.

## Related Documents

- [WARNING_LETTER - 2019-01-18](https://www.keypedia.com/records/warning_letter/greenbrier-international-inc/dc7fc45b-f080-4d19-9a7f-cd6a480fa000)

## Related Officers

- [Rachael O Oyewole, Investigator](https://www.keypedia.com/people/rachael-o-oyewole-investigator/2fcd581d-c929-4fae-a782-30f7f3385f7d)
- [Sony Mathews, Investigator](https://www.keypedia.com/people/sony-mathews-investigator/4843d872-7b90-43b7-b366-ec9ae5afec7f)

Company: https://www.keypedia.com/companies/greenbrier-international-inc/ffd4aebb-7e80-46e1-a5db-1e66b95cdcd9

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