On October 11, 2022, the FDA issued a lengthy warning letter to Nephron SC, a manufacturer of inhalation solutions and suspensions as well as a contract manufacturer of other sterile drug products. The letter does not refer specifically to any inhalation products but notes that the company recently recalled a lot of an injection product and suspended manufacturing of certain products. Nephron previously recalled 10 lots of albuterol inhalation solution in 2013.
According to the warning letter, an FDA inspection that took place from March 28 to April 20, 2022 found “significant violations of Current Good Manufacturing Practice (CGMP) regulations for finished pharmaceuticals,” including problems with cross contamination, microbial contamination, and quality control systems. A banner currently at the top of Nephron’s web site reads, “Nephron is fully inspected and approved by the FDA!”
In March 2020, Nephron CEO Lou Kennedy said that the company wanted to increase production of its inhalation products, which include albuterol inhalation solution, ipratroprium bromide inhalation solution, racepinephrine inhalation solution, and budesonide inhalation suspension; in July of that year, the company announced plans for an expansion of its South Carolina manufacturing facility to meet demand. Shortly afterward, the company announced that it had hired Rita Boucher as Chief Quality Officer. According to LinkedIn, Boucher left Nephron 10 months later.
Read the FDA warning letter.
