Hospira Receives FDA Warning Letter for Repeated Violations

On Feb. 14, 2017, FDA sent a warning letter to Ian C. Reed, chairman and CEO of Pfizer Inc., regarding CGMP violations found at the Hospira, a Pfizer company, McPherson, KS, facility during an inspection conducted from May 16–June 8, 2016. Violations found during the inspection included failure to investigate batch failures and inappropriate measures to prevent microbiological contamination. The agency noted in the warning letter that these violations were a repeat of violations found at four other Hospira sites from 2010–2015.

During the 2016 inspection of the Kansas facility, FDA inspectors found that the company had failed to investigate unexplained batch failures whether or not the batch had already been distributed. Reports were found of multiple instances of visible particles found in sterile injectable products. FDA stated that the company’s investigation of the defects was inadequate and “failed to spur appropriate corrective actions and preventive actions (CAPA).”

The agency pointed to other instances of particles found in Hospira products. In the warning letter, FDA stated, “The presence of multiple foreign particulates in your products is unacceptable. 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.” The agency also stated in the letter that the company waited more than four months to recall product after receiving customer complaints. The agency is asking the company to provide the following:

• A rationale for the company not conducting chemical analysis of the particulates observed in ketorolac tromethamine injection, 30 mg/mL, lot 46205DD, and implementing appropriate actions to prevent recurrence of this event

• Updates on root cause analysis of the particle contamination events and the company’s CAPA plan

• An evaluation of the nature and extent of particulates present in retain samples for all distributed lots of sterile drug products that remain within expiry and for which the company has received complaints of particulate matter

• An evaluation of any released lots that were found to contain intrinsic or extrinsic particulate matter during manufacturing

• Proposed corrective actions to initiate against compromised products that remain on the market. 

Other observations made during the inspection included practices that pose a risk to sterility of finished products such as poor aseptic techniques and poor personnel monitoring techniques. The company failed to establish valid in-process specifications and failed to control rejected in-process materials under a quarantine system. The inspectors also found that Hospira failed to submit required field alert reports to FDA.

The warning letter stated that the violations found at the Kansas facility are a repeat of other observations found at other Hospira locations over the years. “These repeated failures at multiple sites demonstrate that your company’s oversight and control over the manufacture of drugs is inadequate. Your executive management remains responsible for fully resolving all deficiencies and ensuring ongoing CGMP compliance. You should immediately and comprehensively assess your company’s global manufacturing operations to ensure that systems and processes, and ultimately, the products manufactured, conform to FDA requirements,” the agency stated.

Source: FDA