# FDA 483 - RJ General Corporation - January 12, 2022

Source: https://www.keypedia.com/records/483/rj-general-corporation/36fcd151-86a6-4c6c-b208-f52648f24c02

> FDA 483 for RJ General Corporation on January 12, 2022. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: RJ General Corporation
- Inspection Date: 2022-01-12
- Product Type: drugs
- Office Name: Cincinnati District Office
- Summary: An FDA inspection of RJ General Corporation, a drug repackager in Cincinnati, OH, revealed significant deficiencies in its quality control unit and batch production records. The firm lacks a defined quality control unit, written procedures for its responsibilities, and proper documentation for critical production steps. These issues indicate a lack of adequate controls to ensure drug product quality and compliance with GMP requirements.

## Related Officers

- [Regulatory Officer ](https://www.keypedia.com/people/jill-tillman/4fd81eed-0de2-468b-a776-d4809fa91553)

Company: https://www.keypedia.com/companies/rj-general-corporation/02bbc763-17c1-4b87-8547-070a9f8448bd

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