NAC585.520. Investigation of unexplained discrepancies in batches.

Latest version.

     1. A licensee shall immediately order a thorough investigation of any unexplained discrepancy or failure of a batch to meet any of its specifications, whether or not the batch has already been distributed.

     2. The investigation must be undertaken by a competent and responsible person and must extend to other batches of the same drug and other drugs that may have been associated with the specific failure.

     3. The licensee shall make a written record of the investigation, which must include the conclusions and following action.

[Comm’r of Food & Drugs, Amygdalin and Procaine Hydrochl. §§ 4.1.8.1-4.1.8.1.2, eff. 5-15-78]

                    
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