Atlantic Management Resources LTD dba. Claire Ellen Products
FDA issued a warning letter to Atlantic Management Resources LTD dba Claire Ellen Products (Westborough, MA) following a July–August 2022 inspection that found significant CGMP violations in the manufacture of homeopathic drug products, including failure to establish a quality unit, inadequate storage conditions, and absence of batch production records. The firm also distributed 'Neuroquell Plus Cream' without proper FDA drug listing, rendering it misbranded. The company voluntarily ceased production and distribution and issued a nationwide recall in November 2022. FDA warned that failure to address violations could result in seizure, injunction, or withholding of approvals, and required a written response within 15 working days.
Flagged claims (1)
Neuroquell Plus Cream
Required actions (5)
After you receive this letter, respond to this office in writing within 15 working days. Specify identify what you have done to address any violations and to prevent their recurrence.
On November 21, 2022, you issued a voluntary nationwide recall of all drug products.
Failure to promptly and adequately address this matter may result in regulatory or legal action without further notice including, without limitation, seizure, and injunction.
If you plan to resume any manufacturing regulated under the FD&C Act, notify this office prior to resuming your manufacturing operations. If you resume CGMP activities, you are responsible for resolving all deficiencies and systemic flaws to ensure your firm is capable of ongoing CGMP compliance.
you should engage a consultant qualified as set forth in 21 CFR 211.34, to assist your firm in meeting drug CGMP requirements. The qualified consultant should also perform a comprehensive six-system audit of your entire operation for CGMP compliance and evaluate the completion and efficacy of all corrective actions and preventive actions before you pursue resolution of your firm's compliance status with FDA.
Does your site contain similar claims?
The free site audit scans your whole site against every entry in this Atlas. Most pharmacy / compounding sites match 3-6 patterns.
Run my free site auditWorried about one specific page, ad, or email? Paste it into the free Claim Checker and see what the FDA and FTC would flag, with the precedent next to each one. No email required.
Check specific copy in the Claim Checker