Choice All Natural, Inc. dba Om Botanical
FDA issued a warning letter to Choice All Natural, Inc. dba Om Botanical (Apex, NC) following a January–February 2024 inspection that found multiple CGMP violations including pest activity in raw material storage, inadequate finished-product release testing, lack of stability testing, and use of the QC laboratory for meal preparation. The company's 'Om Botanical Rash & Itch Cream' was cited as an unapproved new drug because its combination of Zinc Oxide, Witch Hazel, and Colloidal Oatmeal is not permitted under OTC Monograph M016, and the product was also found misbranded. Additionally, the firm's FDA establishment registration had lapsed since December 31, 2021, and five drug products were not listed with FDA. FDA warned that failure to correct violations may result in seizure, injunction, or withholding of export certificates and new application approvals.
Flagged claims (1)
This topical cream soothes inflamed, irritated, and itching skin...Great for poison ivy and bug bites. Safe enough for diaper rashes…Uses…Temporarily protects and helps relieve minor skin irritation and itching due to ∙ minor cuts ∙ minor scrapes ∙ rashes ∙ poison ivy, oak, or sumac…Helps treat and prevent diaper rash.
Required actions (5)
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.
Failure to promptly and adequately address this matter may result in regulatory or legal action without further notice including, without limitation, seizure and injunction.
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 violations may also cause FDA to withhold issuance of Export Certificates.
We may re-inspect to verify that you have completed corrective actions to address any violations.
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