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21 CFR 310.3 Example 9 Inadequate Stability testing (WL no./date: 560524 - 07/25/2018) In the follow-up visit of the FDA following the issued Form 483, they reported that the firm failed to establish a written testing program designed to assess the stability characteristics of drug products and to use results of such stability testing to determine appropriate storage conditions and expiration dates (21 CFR 211.166(a))

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