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In Brief: Avon

This article was originally published in The Rose Sheet

Executive Summary

Avon: Receives FDA warning letter for Good Manufacturing Practice deviations found during an Oct. 23-24 inspection. The GMP deviations cited in the Dec. 28 letter include: the failure to maintain records showing that the water system used to manufacture drug products has been validated and the "failure to investigate out of specification pH and resistance results" for water used to process products between Oct. 9 and Oct. 23. The warning letter also points out "that there was no data maintained to support the expiration dates of various products." The letter acknowledges that Avon submitted a response concerning the Oct. 23 and 24 investigation, but notes: "While your response appears adequate, it lacks the specificity necessary to ensure correction"...
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