# FDA 483 - Sanitor Corporation - April 14, 2023

Source: https://www.globalkeysolutions.net/records/483/sanitor-corporation/7d4a7f25-e6f5-4398-91e7-1d17e0aa2be4

> FDA 483 for Sanitor Corporation on April 14, 2023. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Sanitor Corporation
- Inspection Date: 2023-04-14
- Product Type: drugs
- Office Name: Division of Pharmaceutical Quality Operations IV
- Summary: Sanitor Corporation, a contract drug manufacturer in Stanton, CA, was cited for five significant deficiencies during an FDA inspection. The observations highlight systemic issues including inadequate quality control unit procedures, compromised data integrity due to poor computer system controls and backup processes, and widespread failures in employee cGMP training. Additionally, the firm failed to establish appropriate storage conditions based on stability testing and maintained inadequate environmental controls for drug products and raw materials.

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## Related Officers

- [Consumer Safety Officer (Inspector)](https://www.globalkeysolutions.net/people/christopher-r-czajka/42defbf3-ea06-4090-8d51-7da2b07d9e84)

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