# FDA 483 - Greene Respiratory Services, Inc. - March 31, 2023

Source: https://www.globalkeysolutions.net/records/483/greene-respiratory-services-inc/85eb4be4-90ab-47ff-9ab3-cfcd028e8728

> FDA 483 for Greene Respiratory Services, Inc. on March 31, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Greene Respiratory Services, Inc.
- Inspection Date: 2023-03-31
- Product Type: drugs
- Office Name: Cincinnati District Office
- Summary: An FDA inspection of Greene Respiratory Services, Inc. in Columbus, OH, a medical gas manufacturer, revealed significant deficiencies in their quality control unit, manufacturing practices, and record-keeping for Oxygen USP. The firm lacked a designated quality control unit, written procedures for critical operations, and proper employee training in current good manufacturing practices. These findings indicate a serious lack of adherence to regulatory requirements for drug product manufacturing.

## Related Officers

- [S. Ponnambalam](https://www.globalkeysolutions.net/people/s-ponnambalam/558b43bb-8210-499e-bcef-400e6c94041d)
- [Consumer Safety Officer , Investigator](https://www.globalkeysolutions.net/people/lisa-r-hilliard/611735cf-5c20-424c-801a-03888d8d1b0a)

Company: https://www.globalkeysolutions.net/companies/greene-respiratory-services-inc/b6ff16af-beda-4b48-a18a-dfdac81de9dd

Office: https://www.globalkeysolutions.net/offices/cincinnati-district-office/b67a0c35-82e3-4176-9039-988378f65c22