Dr. Lewis Clarke M.D. / M. Christopher Clarke
Clarke Pharmaceutical Manufacturing, Inc.
17448 Highway 3 Ste. 141
Webster , TX 77598-4197
United StatesFEI 3010238039Issued Feb 2, 2021Division of Human and Animal Food Operations West III
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 3010238039.
Violations1
Issue DateFeb 2, 2021
Product TypeDrugs
StatusOpen
Letter Details
Firm
Clarke Pharmaceutical Manufacturing, Inc.
Location
Dr. Lewis Clarke M.D. / M. Christopher Clarke
Clarke Pharmaceutical Manufacturing, Inc.
17448 Highway 3 Ste. 141
Webster , TX 77598-4197
United States
FEI Number
3010238039
Country
United States
Issue Date
February 02, 2021
Issuing Office
Division of Human and Animal Food Operations West III
Product Type
Drugs
Status
Open
Summary
Clarke Pharmaceutical Manufacturing, Inc. was cited for manufacturing and selling unapproved new drugs and misbranded products, including OsteoBLAST®, Cell Block #19, High Potency Vitamin D3, Neupanex®, and Natural Progesterone Skin Cream, through their website and YouTube channel without FDA approval. The company made disease claims for these products—such as reducing osteoporosis risk, treating osteoarthritis, and mitigating COVID-19—that established them as drugs under federal law, violating the Federal Food, Drug, and Cosmetic Act. The FDA determined these products were intended to cure, mitigate, treat, or prevent disease and/or affect body structure or function, yet were being distributed into interstate commerce without required drug approvals or proper authorization.
Clarke Pharmaceutical Manufacturing, Inc. FDA Warning Letter, February 2, 2021