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Non-Conformance 2: Failure to Establish and Follow Adequate Aseptic and Contamination Control Procedures Regulatory Citation: 21 CFR 211.113(b) The investigation failures described above are inseparable from weaknesses in Catalents contamination control strategy
Multi-dose vials are punctured multiple times, and each puncture is an opportunity for microbial introduction
A further 20 diketone compounds were procured from Syngenta, which are labelled as dk-1 to dk-12 and dk22 to dk29
While some injectable therapies may use this method, most peptide therapies are administered subcutaneously
