- The Food and Drug Administration has had it with Pfizer, issuing yet another warning letter to the company concerning faulty practices at one of the manufacturing facilities it picked up through acquiring Hospira in 2015.
- Publicly released on Tuesday, the letter speared Pfizer for a medley of Current Good Manufacturing Practice (CGMP) violations at its plant in McPherson, KS, identified during an FDA investigation conducted between May 16 and June 8, 2016. Some of the biggest violations involved contaminants, including several vials of vancomycin hydrochloride that had pieces of cardboard in them.
- "The presence of multiple foreign particulates in your products is unacceptable," the FDA wrote. "Extrinsic contaminants, such as cardboard, pose a significant risk to patients and indicate that your process for manufacturing sterile injectable products is out of control."
Pfizer's Hospira business isn't exactly in the agency's good graces. The agency flagged four other Hospira plants for similar CGMP issues since 2010, though all those warning letters came before Pfizer took over the business.
Still, these newest violations aren't helping reignite confidence in the pharmaceutical giant's manufacturing capabilities.
"These repeated failures at multiple sites demonstrate that your company’s oversight and control over the manufacture of drugs is inadequate," the FDA said in its letter dated Feb. 14.
Pfizer determined the cardboard contaminants in the lot of vancomycin hydrochloride, a penicillin alternative for serious infection, likely stemmed from vial stoppers — a violation that also happened at Porton Biopharma, which received its own warning letter in January. But the FDA countered that Pfizer's investigation wasn't thorough enough, and criticized the company for taking four months to recall the lot after receiving the first complaints about those contaminants.
The violations didn't stop there, either.
Particulate matter also made its way into a lot of an analgesic called ketorolac tromethamine injection. Pfizer sent 10 retention samples for further testing despite finding that 190 contained the contaminants, a decision that the FDA argued was lacking in rationale.
The facility's visual inspection process wasn't sufficient to catch defective products, its sanitation protocol allowed microbes to more easily contaminate drugs and its procedure for reexamining rejected units wasn't properly explained. None of Pfizer's responses to those problems were adequate, according to the letter. What's more, the FDA highlighted Hospira didn't report post-market infractions, such as medication labels peeling off or fading.
Pfizer issued the recall for the lot of contaminated vancomycin hydrochloride on Jan. 24.
"To date, Hospira has not received reports of any adverse events associated with this issue for this lot. Hospira places the utmost emphasis on patient safety and product quality at every step in the manufacturing and supply chain process," the company said in a statement.
Per standard procedure, Pfizer had 15 days after receiving the letter to address the agency's concerns.