Tornado hits Pfizer injectable plant in NC

The Rocky Mount, North Carolina facility, which produces a quarter of Pfizer’s sterile injectables in the US, has been damaged by a tornado.

Drug maker Pfizer confirmed its Rocky Mount plant suffered damage from a tornado, which hit the site on Wednesday. The extent of the damage caused has not been divulged, however a spokesperson for the firm confirmed the site was hit and told BioProcess Insider, “Pfizer colleagues at the site followed our established safety protocol and were able to evacuate. They are safe and accounted for.”

“We are assessing the situation to determine the impact on production. Our thoughts are with our colleagues, our patients, and the community as we rebuild from this weather incident.”

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The facility manufactures almost 25% of sterile injectables used in US hospitals.Over 200 million units are distributed from the Rocky Mount site annually. The plant manufactures various products ranging from therapeutics, anti-infectives, neuromuscular blockers, anesthesia, and analgesia, as well as vials and syringes.

The damage “will likely have minimal financial impact on the company,” analysts from Morgan Stanley wrote in a note, but added it could not rule out that “some” drug shortages may occur.

The US Food and Drug Administration (FDA) provided an update about the damaged facility and said it is “working closely” with Pfizer to assess the situation. Furthermore, the Agency said it will carry-out a more extensive look into products that may have been affected and what this means for their supply.

Rocky problems

Pfizer added the facility as part of its $17 billion acquisition of Hospira in September 2015 but prior to the acquisition, the plant had faced a number of regulatory tick offs from the FDA.

In April 2010, the FDA sent the firm a warning letter regarding concerns about the quality assurance and compliance at the facility and Hospira temporarily closed the plant to deal with the issues.

Two months later, the firm received a Form 483 due to the plant not being in line with good manufacturing practices. And in August 2010, an inspection resulted in another 483 being issued.

Hospira also received a Form 483 in 2013 from the Agency, which listed 20 observations.