Arzol Chemical CompanyJune 14, 2024

FDA 483 - Arzol Chemical Company - June 14, 2024

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Record Details

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.

Company: Arzol Chemical Company
Inspection Date: June 14, 2024
Product Type: Drugs
Office: New England District Office
Person: Tanya R. Syffrard

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ID · 50e45f31-b4d9-401e-bea6-916ad71074a6