# FDA 483 - IntelGenx Corp. - February 25, 2022

Source: https://www.globalkeysolutions.net/records/483/intelgenx-corp/90973ab7-cdbd-4393-b952-e67f7aabedc4

> FDA 483 for IntelGenx Corp. on February 25, 2022. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: IntelGenx Corp.
- Inspection Date: 2022-02-25
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Intelgenx Corp. in Saint-Laurent, a drug manufacturer, was cited for significant deficiencies during an FDA inspection. The firm failed to use stability testing results to support product expiration dates, with multiple batches showing out-of-specification impurity levels due to degradation. Additionally, the company did not formally validate an Excel-based spreadsheet used for critical drug product release calculations, impacting the accuracy and reliability of assay and impurity determinations.

## Related Officers

- [issuing_officer](https://www.globalkeysolutions.net/people/gam-s-zamil/75bc04d4-6013-43b5-8200-8b513c814a7c)

Company: https://www.globalkeysolutions.net/companies/intelgenx-corp/94028878-3a72-4a00-afee-6e3439e993eb

Office: https://www.globalkeysolutions.net/offices/office-of-biological-products-operations-division-i/49c53dac-7724-4c8c-8708-4f5779ea69c1