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Home Industry News Integra Obtains Letter of Caution Regarding Manufacturing Concerns at Boston Facility

Integra Obtains Letter of Caution Regarding Manufacturing Concerns at Boston Facility

18th August 2023

A representative for Integra claimed that the organisation had made advanced improvements to its manufacturing facility.

“We will not resume production until we have addressed the FDA concerns and are confident the facility meets the strictest regulatory and product quality standards, which we anticipate will occur by the end of the calendar year”

The letter concentrated on issues at the facility that produces collagen-based instruments for cartilage repair, injury treatment, and constructive procedures.

The FDA protested about storing sterile equipment in the same location as unsterile products and for failing to act once an issue was detected. The document specifically addressed the way Integra managed problems involving Durepair, a medical device used in neurosurgical treatments that the business produces for Medtronic.

For instance, Integra distributed one batch of Durepair in 2019 that contained more bacterial endotoxin than was permitted. This quantity of endotoxin has the potential to cause illness, but the business claimed that a transcribing fault was to blame for the issue.

The letter also stated that Integra began a safety review to tackle the endotoxin issues during an FDA examination, but it was insufficient and overlooked two cases of meningitis linked to Durepair.

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