River's Edge Pharmaceuticals, LLC – FDA Warning Letter, Aug 12, 2009

An FDA inspection of River's Edge Pharmaceuticals, LLC, from July 13 to August 12, 2009, revealed significant CGMP violations, causing drug products to be adulterated. The company, an own-label distributor using contract manufacturers, also markets unapproved new drugs, violating sections 301(d) and 505(a) of the Act, and these drugs are misbranded under section 502(f)(1).

Violations include: 1. **Lack of scientifically sound specifications:** Products were released despite failing stability tests (e.g., Lidocaine HCl/Hydrocortisone, Selenium Sulfide Shampoo) without scientific rationale for specification changes. 2. **QC unit failure to approve/reject procedures/specifications:** The QC unit failed to reject a lot of RE Pramoxine HC Otic Drops that did not meet assay specifications during stability testing. 3. **QC unit failure to approve/reject contract manufactured products:** The firm did not review Certificates of Analysis (COA) for conformance before product release. 4. **Failure to follow complaint procedures and investigate complaints:** The firm did not review and approve complaints, failed to investigate over 30 complaints of discoloration for Hydroquinone 4% Cream, and did not adequately investigate complaints for red speckles in Reme-Tussin DM cough syrup. 5. **Failure to conduct CGMP training:** Employees