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FDA Warning Letter Renews Concerns About Barring Inspection Photos

This article was originally published in The Rose Sheet

Executive Summary

An FDA warning letter issued in August to OTC drug manufacturer Homeolab has revived discussion about companies' options when it comes to investigator photographs during facility inspections, prompting fresh insight from industry attorneys on the issue's legal underpinning and existing case law.

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FDA Inspection Photography: Pick Your Battles, Cover Your Bases

Firms concerned about trade secrets or other confidential business information have options for resisting photography in the context of FDA inspections, but they should be prepared to be labeled "uncooperative" and could draw a warning letter identifying their offerings as adulterated.

FDA Inspection Photography: Pick Your Battles, Cover Your Bases

Firms concerned about trade secrets or other confidential business information have options for resisting photography in the context of FDA inspections, but they should be prepared to be labeled "uncooperative" and could draw a warning letter identifying their offerings as adulterated.

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