Hospira Manufacturing Facility Handed 483 Over Infusion Pumps

Hospira’s Lake Forest, Ill., manufacturing facility received an FDA Form 483 for quality system deviations related to its infusion pumps, including inadequate design validation, inadequate design change procedures and inadequate corrective and preventive action procedures.

The FDA had issued the Lake Forest facility a 12-item warning letter in May 2013 that chronicled many of the same quality system deviations for its line of infusion pumps.

The firm had not adequately conducted design validation studies to determine the battery life for batteries used in its infusion pumps, the inspector observed during the April 20 to May 27 inspection.

Moreover, the device design was not correctly translated into production specifications, the agency said, noting that the firm’s standard operating procedures don’t mention allowable storage time for batteries. Another SOP mentions the wrong batteries used in the infusion pumps, according to the 483.

The firm also failed to establish adequate design change procedures when it extended incoming acceptance criteria that did not include any testing.

In addition, CAPA procedures were not adequately established to investigate causes of quality problems, according to the 483.

Specifically, in a CAPA exception report related to a battery issue, the company identified human error as the root cause, and the FDA inspector cited the firm for failing to determine the impact of the improper design.

The inspector also noted that the firm retrained personnel as a corrective action, but it did not evaluate the adequacy of the manufacturing procedures. For example, the firm didn’t perform an effectiveness check to make sure the actions eliminated the reoccurrence of the nonconforming product or other quality problems.

The agency also said the firm’s nonconformance procedure does not describe a clear process for establishing frequency of nonconforming events, and procedures don’t take into account the scope of problems.

The company has been riddled with global quality issues in both its drug and device areas in recent years. In March, the FDA handed Hospira its seventh warning letter in seven years.

Hospira did not respond to requests for comment.

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