Nephron follow-up inspection results in no warning.(Human Drugs)

Nephron Pharmaceuticals received a clean bill of health following a Feb. 7-11, 2008, inspection. The assessment was a follow-up to a 2007 investigation, which resulted in a 483. At the time, Nephron was required to comply with official actions and voluntarily destroyed certain drug products.

The Orlando, FL, firm, which manufactures bronchodilators, had been cited in the previous inspection for the labeling on its racepinephrine inhalation solution 2.25% product that indicated it could be used for viral croup. FDA investigator Kelly Anderson noted that this indication did not follow the OTC drug monograph for the product and represented an unapproved claim. Nephron conducted a voluntary destruction of labels, cartons, inserts and products following the earlier inspection.

Anderson reported in the EIR following the latest inspection that Lou Kennedy, owner and CEO of Nephron, stated that the company does not carry any promotional materials that make the viral croup claim. Regulatory Affairs Manager Ayanna Brown stated that the company chose to remove the unapproved claim from its product labeling and promotions rather than apply for an NDA because the latter course would cost approximately $1.5 million.

Anderson observed a display case in Nephron's lobby that contained product with the labeling that included the viral croup claim; however, this was removed before the close of inspection and the FDAer confirmed after reviewing the company's batch records and other materials that the viral croup claim has been removed from product labeling. Nephron Pharmaceuticals, Orlando, FL, 2/7-11/08, Doc. 110123M, $5 plus retrieval

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