# FDA 483 - Quality CDMO - June 16, 2023

Source: https://www.keypedia.com/records/483/quality-cdmo/5067cfa6-ea85-4517-ae8e-91e1878fd7e5

> FDA 483 for Quality CDMO on June 16, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Quality CDMO
- Inspection Date: 2023-06-16
- Product Type: drugs
- Office Name: Division of Human and Animal Food Operations - West III
- Summary: An FDA inspection of QUALITY CDMO, Inc. in Fort Worth, TX, a drug manufacturer, revealed significant deficiencies in their manufacturing processes. The firm failed to validate drug manufacturing equipment, equipment qualifications, and cleaning procedures for OTC and Rx drug products. Additionally, the quality control unit lacked proper authority for change control, and the firm had not established hold time studies for bulk drug products.

## Related Officers

- [Investigator](https://www.keypedia.com/people/marvin-d-jones/3101a8da-f5c1-4e0c-b4b1-b09be181be36)
- [Program Coordinator](https://www.keypedia.com/people/martrice-a-packer/e9d89635-6323-4dc7-9222-c44cedcf46c2)
- [Investigator](https://www.keypedia.com/people/regan-t-harp/f27e8e4f-2a75-4c4b-8c3e-f8f8ca0717f3)

Company: https://www.keypedia.com/companies/quality-cdmo/f75037f8-af7a-442d-914f-8739cb866e45

Office: https://www.keypedia.com/offices/division-of-human-and-animal-food-operations-west-iii/2cda09a5-06c4-433f-9df0-0d7903a6efab