Pharma Pac's skipped step
For Pharma Pac, the issues were fundamental: approvals and labeling. Warning letter 2009-NOL-08, which followed a late June through mid-July inspection of a plant in De Kalb, MS, says investigators found the company manufacturing and marketing unapproved and misbranded antihistamine/nasal decongestant drugs.
"Based on our information, there are no FDA-approved applications on file for these drug products," the letter says. "Additionally, because the drugs are intended for conditions not amenable to self-diagnosis and treatment by individuals who are not medical practitioners, adequate directions cannot be written for them. Consequently, their labeling fails to bear adequate directions for use."
Inspectors also found that the combination of ingredients identified on the label of an over-the-counter skin protection product was unauthorized in the appropriate monograph. And listed ingredients lacked the "active" and "inactive" headings. "Since these ingredients are not differentiated, they are all represented as contributing to the claimed effect and thus are ‘active ingredients' as defined by code. This combination of active ingredients is not authorized in any monograph."
Given the lack of a corresponding monograph, inspectors said they were unaware of any evidence establishing that "healing skin therapy lotion," as formu1ated and labeled, is recognized among scientific experts as safe and effective. "We are unaware of any evidence documenting a product so formu1ated and labeled was marketed in the United States on or before the inception of FDA's OTC Drug Review. Therefore, healing skin therapy lotion does not qualify for inclusion in any of the ongoing rulemakings under the OTC Drug Review."