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FDAnews Drug Daily Bulletin
Sept. 17, 2012 | Vol. 9 No. 182
Lax Environmental Controls Draw Form 483 for Alliance Medical Products
Alliance Medical Products, a contract manufacturer of commercial and clinical drugs, failed to follow environmental monitoring plans in classified areas and storage rooms, an FDA Form 483 states. Certain data regarding the setting of temperature and pressure limits is not reviewed by management per company protocol, FDA investigators said following a mid-April inspection.
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