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Adulterated OTCs Reach Dollar Tree, Third-Party Test Lab Missed Problems

Executive Summary

Warning links retailers to multiple manufacturers inspected after FDASIA in 2012 pointed FDA toward inspecting all ex-US firms supplying products available in US but that had yet to be inspected for compliance. Manufacturers also were placed on import alerts to prevent their products, including cosmetics as well as drugs, from reaching US.

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US FDA Warns Second Ningbo, China, OTC Firm In Two Weeks On Violations

Hand sanitizer, shampoo, acne scrub, other products available in US under brands including AuraFresh, Halsa, Spa Mystique deemed adulterated due to GMP problems found during an inspection at Pulisi Daily's facility in  city in Zhejiang Province.

Warnings Up As FDA Trims Its List Of Uninspected OTC Drug Manufacturers

Hundreds of foreign OTC drug firms marketing products in US had not been inspected for GMP compliance before FDA Safety and Innovation Act of 2012 pointed agency toward crossing those facilities off its list. Of the foreign OTC facilities inspected between June 2016 and January 2018, 25% received "official action indicated" inspection results, prompting warning letters and import alerts.

Manufacturing Compliance Updates In Brief: A Reduced Focus On Data Integrity

US FDA has issued at least 10 GMP warning letters in February and March to drug and API manufacturers in China, India, France, South Korea, Hong Kong, the Dominican Republic and the US. Common problems seen are failure to validate manufacturing processes, inadequate testing to conform that products meet specifications, and inadequate safeguards to prevent microbiological contamination, yet in a recent turn, only a few manufacturers had data integrity problems. FDA posts Form 483 reports issued to four manufacturers in India for GMP violations and adds six facilities to its drug GMP import alert.

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