Mr. Sudhir Shah
President
Choice All Natural, Inc. dba Om Botanical
1019 Classic Road
Apex , NC 27539-4402
United StatesFEI 3015097434Issued Oct 21, 2024Center for Drug Evaluation and Research (CDER)
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 3015097434.
Violations7
Issue DateOct 21, 2024
Product TypeDrugs
StatusOpen
Letter Details
Firm
Choice All Natural, Inc. dba Om Botanical
Location
Mr. Sudhir Shah
President
Choice All Natural, Inc. dba Om Botanical
1019 Classic Road
Apex , NC 27539-4402
United States
FEI Number
3015097434
Country
United States
Issue Date
October 21, 2024
Issuing Office
Center for Drug Evaluation and Research (CDER)
Product Type
Drugs
Status
Open
Summary
Choice All Natural, Inc. dba Om Botanical received a warning letter for manufacturing drug products that violated Current Good Manufacturing Practice (CGMP) regulations, rendering them adulterated under federal law. The company failed to properly register with the FDA and failed to list five drug products—including "Om Botanical Rash & Itch Cream," "Acne Treatment," "Eczema & Psoriasis Relief," "Pain Relief," and "Reef Safe Sunscreen SPF 30"—as required by law. Additionally, the "Om Botanical Rash & Itch Cream" product was identified as an unapproved new drug and misbranded product introduced into interstate commerce in violation of FDA regulations.
Choice All Natural, Inc. dba Om Botanical FDA Warning Letter, October 21, 2024
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