Hospira Warning Letter Issued by US FDA

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.

View the full Hospira US FDA Warning Letter

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