Hospira Receives FDA Warning Letter for Drug Manufacturing ViolationsOct 2, 2014
On Wednesday, Hospira Inc. said it had received a warning letter from the Food and Drug Administration (FDA) after an inspection of its Australian manufacturing facility identified "significant violations" of current good manufacturing practice (CGMP).
The warning letter was sent because, among other violations, FDA inspectors discovered "visible particles" in an injectable drug during an inspection at Hospira’s facility in Mulgrave, Victoria, in February 2014, The Wall Street Journal reports. Hospira, based in Lake Forest, Illinois, said it was evaluating what actions it would take but the company said it intends to respond fully to the warning letter.
The FDA letter said Hospira’s response to the inspection report lacked “sufficient corrective actions.” In addition to the concern about visible particles in samples of carboplatin, a chemotherapy drug, the FDA raised concerns about purity and consistency of batches and the stability of finished products. “Your firm failed to establish written procedures for production and process control designed to assure that the drug products you manufacture have the identity, strength, quality, and purity they purport or are represented to possess,” the letter states. The issue with carboplatin dates back to 2012, but it was not until March 2014 that Hospira sent a letter to health care providers recommending visual inspection of the vials and use of a filter before administration of the drug.
Hospira has 15 business days from the date it received the letter to notify the FDA of steps it has taken to correct the violations. If the violations are not corrected, the FDA could take additional action, including the refusal to admit into the U.S. products manufactured at the Australian facility.