# FDA 483 - Du-Var Laboratory - October 20, 2023

Source: https://www.keypedia.com/records/483/du-var-laboratory/e1cfa44f-1d48-49ab-a1be-1dedf7f5802a

> FDA 483 for Du-Var Laboratory on October 20, 2023. Product: drugs. Access full analysis and detailed observations.

---

## Details

- Record Type: 483
- Company Name: Du-Var Laboratory
- Inspection Date: 2023-10-20
- Product Type: drugs
- Office Name: Office of Biological Products Operations - Division I
- Summary: Du-Var Laboratory, a contract manufacturer in Boucherville, was cited with four observations during an FDA inspection from October 12-20, 2023. The inspection revealed significant deficiencies in quality control, including a failure to validate manufacturing and packaging processes for OTC drug products, inadequate cleaning validation, and insufficient investigation of microbial excursions in water samples. These issues indicate a lack of robust quality systems to ensure drug product identity, strength, purity, and quality.

## Related Officers

- [Drug Investigator](https://www.keypedia.com/people/jessica-s-estriplet/b7152ec3-6e1b-45aa-840e-7147f357aea2)

Company: https://www.keypedia.com/companies/du-var-laboratory/61ad1260-b143-4968-b59d-1b551a62addf

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