# FDA 483 - Robert's Oxygen Company Inc. - April 10, 2019

Source: https://www.globalkeysolutions.net/records/483/roberts-oxygen-company-inc/943dd70c-2c60-4fdc-b9d7-9b4402e72886

> FDA 483 for Robert's Oxygen Company Inc. on April 10, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Robert's Oxygen Company Inc.
- Inspection Date: 2019-04-10
- Product Type: drugs
- Office Name: Atlanta District Office
- Summary: Robert's Oxygen Company Inc. in Charlotte, NC, was inspected regarding its medical and food grade gas manufacturing operations. The inspection revealed a significant deficiency in batch production and control records, specifically the absence of complete labeling control records for drug products. This indicates a failure to maintain proper documentation for the labeling and lot numbering of manufactured medical and food grade gases.

## Related Officers

- [Laura D. Cain](https://www.globalkeysolutions.net/people/laura-d-cain/aac6f4dc-d9d0-4945-91c3-ae544a322df7)

Company: https://www.globalkeysolutions.net/companies/roberts-oxygen-company-inc/bf101b9e-8c77-4f55-b646-cf387a977644

Office: https://www.globalkeysolutions.net/offices/atlanta-district-office/7586d99a-288e-49d1-8c3d-d88b7354b7a7