# FDA 483 - Arzol Chemical Company - June 14, 2024

Source: https://www.keypedia.com/records/483/arzol-chemical-company/50e45f31-b4d9-401e-bea6-916ad71074a6

> FDA 483 for Arzol Chemical Company on June 14, 2024. Product: drugs. Access full analysis and detailed observations.

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## Details

- Record Type: 483
- Company Name: Arzol Chemical Company
- Inspection Date: 2024-06-14
- Product Type: drugs
- Office Name: New England District Office
- Summary: Arzol Chemical Company, a drug manufacturer in Keene, NH, received a Form 483 with four observations. The inspection revealed significant issues including inadequate process validation for Silver Nitrate Applicators, insufficient testing of incoming Active Pharmaceutical Ingredients, and a deficient vendor qualification program for contract laboratories. Additionally, the firm lacked adequate systems for Drug Supply Chain Security Act compliance.

## Related Officers

- [Tanya R. Syffrard](https://www.keypedia.com/people/tanya-r-syffrard/a78a42b3-6cef-46d9-9698-ec6082956477)

Company: https://www.keypedia.com/companies/arzol-chemical-company/08a68b2c-a246-449c-adcd-290d48a7ece4

Office: https://www.keypedia.com/offices/new-england-district-office/aa458072-2f1d-4231-89f5-21ba7a3b7144