# FDA WARNING_LETTER - River's Edge Pharmaceuticals, LLC - August 12, 2009

Source: https://www.keypedia.com/records/warning_letter/rivers-edge-pharmaceuticals-llc/7c3e07a7-6d88-45f1-859b-98c206ff8dce

> FDA WARNING_LETTER for River's Edge Pharmaceuticals, LLC on August 12, 2009. Product: Drugs. Access full analysis and detailed observations.

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## Details

- Record Type: WARNING_LETTER
- Company Name: River's Edge Pharmaceuticals, LLC
- Inspection Date: 2009-08-12
- Product Type: Drugs
- Office Name: Atlanta District Office
- Summary: 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

## Related Officers

- [John R. Gridley](https://www.keypedia.com/people/john-r-gridley/32a64db5-8914-4eb2-93ea-e41da190edd7)
- [Philip S. Campbell](https://www.keypedia.com/people/philip-s-campbell/8d52c26d-9e17-4619-9728-1de39737069b)
- [Dr.](https://www.keypedia.com/people/sally-loewke/a99f92f5-396d-4b10-be67-99316a9408bd)

Company: https://www.keypedia.com/companies/rivers-edge-pharmaceuticals-llc/ef1676dd-7960-4a7d-97d1-5b06355a1aef

Office: https://www.keypedia.com/offices/atlanta-district-office/7586d99a-288e-49d1-8c3d-d88b7354b7a7