Atlantic Management Resources LTD dba. Claire Ellen Products

Warning LetterOpen

United StatesIssued Jan 20, 2023Division of Pharmaceutical Quality Operations I

View Letter

Source: FDA, published letter. FDA published this warning letter; View Letter opens FDA's copy.

Violations3

Issue DateJan 20, 2023

Product TypeDrugs

StatusOpen

Letter Details

Firm: Atlantic Management Resources LTD dba. Claire Ellen Products
Location: United States
FEI Number: N/A
Country: United States
Issue Date: January 20, 2023
Issuing Office: Division of Pharmaceutical Quality Operations I
Product Type: Drugs
Status: Open

Summary

Atlantic Management Resources LTD dba. Claire Ellen Products, a drug manufacturer in Westborough, MA, violated Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals during an FDA inspection conducted July-August 2022. The company failed to properly list drug products with the FDA and distributed drugs under its own name and label without required FDA registration, rendering the products misbranded and adulterated. These violations of the Federal Food, Drug, and Cosmetic Act prohibited the introduction or delivery of such products into interstate commerce.

Atlantic Management Resources LTD dba. Claire Ellen Products FDA Warning Letter, January 20, 2023