Home > Newsletters > The QMN Weekly Bulletin > Lax Environmental Controls Draw Form 483 for Alliance Medical Products
The QMN Weekly Bulletin
Sept. 14, 2012 | Vol. 4 No. 37
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. Environmental limit data in one area of the company’s Irvine, Calif., plant is required to be generated for periodic verification, but the data generated is incomplete, the form states.
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