The QMN Weekly Bulletin

Pfizer Subsidiary Cited for Lax Supplier Oversight, Quality Failures

Dec. 6, 2013

The FDA is maintaining pressure on Pfizer subsidiary Meridian Medical Technologies, a maker of drug auto-injectors, to improve quality at its Missouri plants.

The agency has published three 483s it has issued to the company’s plants in St. Louis and Brentwood, Mo., over the last two years, citing them for failing to audit suppliers, inadequate testing of incoming raw materials, poor batch records and other quality problems.

Meridian has come under fire from congressmen who are angry about quality deficiencies at the company, which manufactures nerve gas antidote for the Department of Defense.

In a 483 handed to Meridian’s Brentwood, Mo., facility in March, the agency found that an investigation into an out-of-specification result for a diazepam auto-injector product was not thoroughly conducted to detect root cause. The company linked the cause to raw materials, but had not previously audited the supplier. Meridian’s investigation also did not include any testing of supplied diazepam for impurity, according to the FDA.

Meridian also never inspected its contract testing laboratory used to analyze batches for foreign material, the FDA says.

The FDA also faulted procedures used for visual inspections of batches at Meridian’s Saint Louis, Mo., facility, according to a 483 issued in April. At least one visual inspection, intended to ensure there are no missing products, failed to detect missing atropine sulfate injection, the agency said. While the batch was reworked, Meridian did not investigate whether the visual inspection failed for other lots, according to the FDA.

The agency also published a 483 detailing an early 2012 inspection of the Brentwood plant. Investigators found that batch records did not have the actual times manufacturing steps were started and stopped, but rather “theoretical times,” according to the form.

Pfizer is working “in close cooperation with the FDA to address these matters and corrective actions are ongoing,” spokesman Chris Loder said. Loder declined to detail the corrective actions applied.

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