# FDA 483 - Regenesis Pharmaceutical Inc. - June 18, 2019

Source: https://www.globalkeysolutions.net/records/483/regenesis-pharmaceutical-inc/70f29843-fbcc-4f8c-aa7d-41a190790396

> FDA 483 for Regenesis Pharmaceutical Inc. on June 18, 2019. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Regenesis Pharmaceutical Inc.
- Inspection Date: 2019-06-18
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: An FDA inspection of Regenesis Pharmaceutical Inc. in Santa Ana, CA, a manufacturer and labeler of Pain Killer Natural Ointment, revealed numerous significant cGMP violations. The firm lacked fundamental written procedures and documentation across its quality control unit, employee training, complaint handling, material and finished product testing, batch recordkeeping, process validation, stability testing, reserve sample retention, equipment maintenance, calibration, and labeling controls. These deficiencies indicate a severe lack of adherence to good manufacturing practices.

## Related Officers

- [Alan L. Truong](https://www.globalkeysolutions.net/people/alan-l-truong/8b9c59ed-ce68-44c3-9fbe-07cc3da13713)

Company: https://www.globalkeysolutions.net/companies/regenesis-pharmaceutical-inc/e74e384c-018e-4735-b2f2-7cf6dd27a8fa

Office: https://www.globalkeysolutions.net/offices/division-of-pharmaceutical-quality-operations-iv/a2d2ff91-dc0f-433e-b91f-ca90ff8998b6