On February 14, 2017, an US Food and Drug Administration (USFDA) Warning Letter was issued to Hospira. This Warning Letter was issued for significant violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. These violations lead to the drug products beingadulterated under the Federal Food, Drug, and Cosmetic Act (FD&C Act).
Hospira is a drug manufacturing facility owned by Pfizer. The Kansas City District Office inspected Hospira for nearly a month between May 16 to June 8, 2016. . The violations included
–Failure to submit field alert reports to FDA
–Failure to thoroughly investigate unexplained discrepancies or failures of a drug batch to meet specifications
–Failure to have valid in-process specifications
–Failure to follow procedures to prevent microbiology contamination of sterile drugs
–Failure to control rejected in-process materials
–Failure to establish laboratory controls
–Repeat violations at multiple facilities.
