Pfizer blames Canadian EpiPen shortage on manufacturing complexities

By Dan Stanton contact

- Last updated on GMT


Related tags: Manufacturing, Food safety

Pfizer says ongoing remediation to the quality validation process at its supplier has resulted in a shortage of EpiPen auto-injectors in the 0.3 mg format.

A shortage of EpiPen (0.3mg) auto-injectors due to a manufacturing disruption is expected to last until early March, Health Canada announced last week.

Pfizer, which markets the adrenaline (epinephrine) delivery device in Canada, told this publication it is not unusual for EpiPen auto-injectors to be on backorder for limited periods of time due to “manufacturing complexities and relatively short shelf lif​e” of the product.

“The supply interruption is due to manufacturing delays related to the implementation of improvements to the quality validation processes that are now in place at the manufacturing facility,”​ a spokesperson from Pfizer Canada said.

“Pfizer Canada is managing this supply interruption as a priority and is working diligently to restore supply of EpiPen 0.3 mg auto-injectors in Canada.”

Manufacturing warning letter

Pfizer subsidiary Meridian Medical Technologies makes the device from its facility in St. Louis Missouri, US.

In September, the facility received a warning letter​ summarizing significant violations of current good manufacturing practice (cGMP) requirements for combination products from the US Food and Drug Administration (FDA).

Among the violations, the Agency cited failures in investigating and explaining component and product failures for EpiPen products, “including failures associated with patient deaths and severe illness.” ​The FDA also noted repeat cGMP violations from an inspection in 2014.

The problems at the facility have led to a number of product recalls​ by customer Mylan – which markets EpiPen across a number of markets.

“Pfizer is continuing to work with the FDA to resolve the points raised in the warning letter regarding Pfizer’s manufacturing of the EpiPen products,”​ Mylan said in September.

“The warning letter does not affect Pfizer’s ability to manufacture and supply the EpiPen products from the Brentwood, Missouri site, and the Company does not currently anticipate any impact on the supply of EpiPen products based on this warning letter.”

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