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Visual Signs in Lyophilized Peptide Normal: White to off-white fluffy powder, loosely filling the vial Concern: Powder appears wet, compacted, or stuck to the vial wall suggests moisture ingress Concern: Visible yellow or brown discoloration may indicate oxidative degradation Concern: Vial seal is damaged or stopper appears compromised potential contamination Visual Signs in Reconstituted Peptide Normal: Clear, colorless to very pale yellow solution, free of visible particles Concern: Cloudiness or turbidity suggests aggregation or contamination Concern: Visible particulate matter suggests degradation or contamination Concern: Strong or unusual odor suggests microbial contamination If any of these signs are present, do not use the material

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Then, in the days leading up to the hearing, controversy surrounding these new industry-connected panelists prompted the FDA to again add eight new experts to the hearing, bringing the total number of voting individuals to 14