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Florida Firm's OTC Tattoo Pain Relief Get FDA's Unapproved Stamp

This article was originally published in The Pink Sheet

Executive Summary

FDA warning based on an inspection of AIG Technologies' facility from September through November 2015. The firm responded without "supporting documentation" to FDA and the agency has been unable to verify the adequacy of its corrective actions.

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FDA expects Pain Relief Naturally to recall lidocaine-containing hemorrhoid, bed sore and pre-tattoo lotions and sprays. In addition to GMP problems, formulations and labeling for Naturally Healthy Living brand products are noncompliant with US FDA's for external analgesic OTC monograph and other agency rules.

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