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Description
BPC-157s discovery in the 1990s marked a scientific milestone
These include coding mistakes, missing documentation, or insurance problems
Similar to the 18 letters issued in FY22, FDA underscored the responsibilities of both the contract manufacturer(s) and the product sponsor in 19 letters in FY23
Product priced significantly below the cost of compliant manufacturing warrants questions about which manufacturing or testing steps were omitted to achieve that margin
