# FDA 483 - Sanitor Corporation - June 03, 2021

Source: https://www.globalkeysolutions.net/records/483/sanitor-corporation/95d75d2b-1876-47e7-aa71-ce404ca41b4f

> FDA 483 for Sanitor Corporation on June 03, 2021. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Sanitor Corporation
- Inspection Date: 2021-06-03
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: Sanitor Corporation, a drug product manufacturer in Stanton, CA, was inspected by the FDA from May 25 to June 3, 2021. The inspection revealed significant deficiencies across quality control, production, laboratory controls, and personnel training, particularly concerning the release of drug products without complete testing, inadequate investigations into microbial failures, and issues with data integrity and stability programs. These findings indicate a systemic lack of adherence to cGMP regulations, posing potential risks to product quality and patient safety.

## Related Documents

- [WARNING_LETTER - 2021-06-03](https://www.globalkeysolutions.net/records/warning_letter/sanitor-corporation/e688ae6a-4f4f-4b7f-a784-a6cccb008c7f)
- [483 - 2023-04-14](https://www.globalkeysolutions.net/records/483/sanitor-corporation/7d4a7f25-e6f5-4398-91e7-1d17e0aa2be4)

## Related Officers

- [issuing_officer](https://www.globalkeysolutions.net/people/khoa-nathan-v-tran/678e5634-237c-4395-88a1-7418479e83c7)
- [Hung H. Do](https://www.globalkeysolutions.net/people/hung-h-do/580f78ba-ed7a-4c10-8f4c-a99d0af7206e)
- [Wenzheng Zhang](https://www.globalkeysolutions.net/people/wenzheng-zhang/44b1afce-5ba2-4013-82ac-52c6374c0be4)
- [Professor](https://www.globalkeysolutions.net/people/liming-zhang/6c93b721-8725-4d87-8a42-254f3de5e49d)

Company: https://www.globalkeysolutions.net/companies/sanitor-corporation/99144124-9868-4094-bfdf-73d3aa7edf40

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