rose stone enterprises – FDA Warning Letter

On November 16, 2011, the FDA issued a Warning Letter to Hub Pharmaceuticals, LLC, specifically addressing Ms. Cyndy Rosenstein, President and CEO. The letter concerns the distribution of unapproved new drugs, namely Fluorescein Sodium Injections (100 mg/ml and 250 mg/ml, both "Lite" and "Dark" versions).

The FDA determined these products are "new drugs" under section 201(p) of the Act because they are not generally recognized as safe and effective for their labeled uses. Consequently, their introduction into interstate commerce without an FDA-approved application violates sections 301(d) and 505(a) of the Act.

Additionally, as prescription drugs, their labeling lacks adequate directions for lay use, causing them to be misbranded under section 502(f)(1) of the Act, a violation of section 301(a).

The FDA stated it would not initiate enforcement action for manufacturing if it ceases within 90 days, or for distribution if it ceases within 180 days. This enforcement discretion is voided if other violations occur, distribution volume increases, or new serious health risks are identified.

Hub Pharmaceuticals was required to respond within fifteen working days, detailing plans to cease violative activities, reasons and dates for cessation, information on other manufacturers/suppliers, and progress in updating FDA's Drug