Premier Trends LLC

Warning LetterOpen

Ms. Shabana Baig President/Co-Owner Premier Trends LLC 4 Elisa Drive Monroe Township , NJ 08831-3527 United StatesFEI 3014373428Issued Mar 14, 2022Division of Pharmaceutical Quality Operations I

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Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy. To check it, open FDA's record for this establishment, listed under FEI 3014373428.

Violations8

Issue DateMar 14, 2022

Product TypeDrugs

StatusOpen

Letter Details

Firm: Premier Trends LLC
Location: Ms. Shabana Baig President/Co-Owner Premier Trends LLC 4 Elisa Drive Monroe Township , NJ 08831-3527 United States
FEI Number: 3014373428
Country: United States
Issue Date: March 14, 2022
Issuing Office: Division of Pharmaceutical Quality Operations I
Product Type: Drugs
Status: Open

Summary

Premier Trends LLC was cited for significant Current Good Manufacturing Practice (CGMP) violations at its New Jersey drug manufacturing facility during a September 2021 inspection, rendering its "Magic Heal" product adulterated and misbranded. The company failed to maintain proper manufacturing, processing, packing, or holding controls for finished pharmaceuticals, and was not registered as required under federal law; additionally, the firm had discontinued its drug listing for Magic Heal in November 2020 without relisting it. The FDA determined that Magic Heal, marketed with claims about skin protection and treating rough and cracked skin, constituted a drug product subject to CGMP requirements, and the company's October 2021 response to inspection findings was deemed inadequate due to insufficient detail and corrective action evidence.

Premier Trends LLC FDA Warning Letter, March 14, 2022