FDA Sent Warning Letter To Teva Pharmaceuticals Industries. The U.S. Food and Drug Administration (FDA) has sent a warning letter to Teva Pharmaceutical Industries Ltd on October 14, 2016. The warning letter is associated with an FDA Current Good Manufacturing Practices (CGMP) inspection of Teva’s manufacturing facility.
The FDA letter cites deficiencies in manufacturing operations and laboratory controls. Also in question is Teva’s data integrity program. Corrective actions are being undertaken to address particular concerns as well as underlying causes of those concerns Reuters reports.
The FDA’s inspection of the company’s Godollo, Hungary manufacturing facility was conducted from January 21, 2016 through January 29, 2016.
Teva is a manufacturer of specialty and generic pharmaceuticals
Teva is a manufacturer of specialty and generic pharmaceuticals. It experienced numerous and significant recalls in 2014. An example is a recall of nearly 130,000 cartons of Tev-Tropin human growth hormone for children because of concerns that oil leaked into the medication, reports FiercePharmaManufacturing. Before that Teva issued another recall of over 1 million bottles of its then-released generic version of Eli Lilly’s antidepressant, Cymbalta.
In August 2016, a voluntary recall was issued by Teva Pharmaceuticals of seven lots of Amikacin Sulfate Injection USP vials due to a potential presence of glass particles. If glass matter is introduced in an intravenous drug, there may be local irritation or swelling caused by a reaction to the foreign matter.
Other severe possible outcomes may be blockage and clotting in blood vessels, which may be life-threatening if a critical organ is affected. One in every nine prescriptions dispensed in the United States is a Teva product.