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HCT/P Case Presentations: Adverse Reactions and Product Deviations
E. Richard Jordan, BBA, CEBT, CTBS
Reporting adverse reactions and biologic product deviations on occasion can be confusing to those who may, fortunately, not have to do such reporting frequently. The following case studies are presented to assist in the review of situations where such reporting may be required by the Food and Drug Administration to fulfill one or more of its regulations. These requirements can be found in 21 CFR part 1271.350.