Issued: 10/25/11
Region: Southwest
Category: Drug 483s
Inspection date range: 10/12/11-10/25/11
Pages: 7
Company: Nexgen Pharma, Inc.
1835 E. Cheyenne Rd.
Colorado Springs, CO 80905
Inspector(s): Larisa E. Pavlick, Caroline H. Le
Observations: You did not provide adequate documentation of your basis for determining that compliance with the specifications you selected for identity, purity, strength, and composition will ensure that the finished batch of dietary supplement meets the specifications.
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