FDA warns Hospira to clear up flaws in injectable manufacturing

The FDA sent a letter warning Hospira Inc., a Pfizer Company, that some of the manufacturer’s drugs are adulterated due to violations of current good manufacturing practice (CGMP) regulations for finished pharmaceuticals. Following an FDA inspection, the agency identified a number of CGMP failures, including a lack of adequate controls, the presence of visible particulates in sterile injectable products, and inadequate procedures to prevent contamination. The FDA noted that the failure to promptly correct the identified violations could result in seizure and injunction.

The FDA inspected Hospira’s McPherson, Kansas, facility from May 16 to June 8, 2016. The inspection revealed violations of the federal Food, Drug, and Cosmetic Act (FDC Act) (21 U.S.C. § 351(a)(2)(B)), as well as federal regulations (21 C.F.R. parts 210 and 211). Some of the violations stemmed from inadequate investigation, including multiple instances where Hospira determined that visible particulate in sterile injectable products were pieces of cardboard but closed the investigations without taking further corrective action. The inspection also identified poor aseptic technique due to the use of unsterilized materials in an aseptic manufacturing environment. The FDA also determined that Hospira failed to submit field alert reports to the agency after the manufacturer identified numerous cases of extensive label deterioration.

An announcement by Momenta Pharmaceuticals, Inc. indicates the company’s position that the warning letter should not impact the production of Momenta’s Glatopa™ 20 mg (glatiramer acetate injection) product, which is filled and finished by Pfizer. However, Momenta’s Glatopa 40 mg abbreviated new drug application (ANDA), which is still under FDA review, is dependent on the “satisfactory resolution of the compliance observations at the Pfizer facility used to make the final product.” As a result, Momenta indicated that approval in the first quarter of 2017 is unlikely.