Brands International Corporation
FDA issued a warning letter to Brands International Corporation (Lakewood, NJ / Newmarket, Ontario) after a June 2024 inspection found the firm obstructed investigators, failed to adequately investigate mold contamination complaints, released drug products without proper active-ingredient testing, and stored APIs outdoors without climate control. The firm's drugs were deemed adulterated under multiple provisions of the FD&C Act, FDA placed the firm on Import Alert 66-40, and two voluntary recalls were initiated for mold-contaminated products. FDA demanded comprehensive corrective action plans, CGMP consultant engagement, and a written response within 15 working days.
Required actions (8)
After you receive this letter, respond to this office in writing within 15 working days. Specify what you have done to address any violations and to prevent their recurrence.
FDA placed products offered for import into the United States from your firm on Import Alert 66-40 on October 28, 2024.
FDA may withhold approval of new applications or supplements listing your firm as a drug manufacturer until any violations are completely addressed and we confirm your compliance with CGMP.
Failure to address any violations may also result in the FDA continuing to refuse admission of articles manufactured at Brands International Corporation, located at 594 Newpark Blvd, Newmarket, Ontario L3X 2S2, Canada, into the United States under section 801(a)(3) of the FD&C Act, 21 U.S.C. 381(a)(3).
Based upon the nature of the violations we identified at your firm, you should engage a consultant qualified as set forth in 21 CFR 211.34 to evaluate your operations and to assist your firm in meeting CGMP requirements.
On June 10, 2024, you initiated a voluntary recall of Kissable Oatmeal Daily Moisturizing Body Lotion due to the presence of mold contamination.
On November 13, 2024, you initiated a voluntary recall of additional products due to CGMP violations and potential mold contamination.
We may re-inspect to verify that you have completed corrective actions to any violations.
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