The Food and Drug Administration (FDA) has sent a warning letter to Integra LifeSciences Holding Corporation in regard to quality systems issues at its manufacturing facility in Andover, England. The letter followed a June 2012, inspection of the facility.
The warning letter cited inadequate CAPA (corrective action preventive action) compliance, lack of testing documentation, missing self-imposed timelines and a failure to have a customer service rep at quality management review meetings.
Integra officials note that the warning letter does not restrict the company’s ability to manufacture or ship products or import them into the United States. Neither does it require the recall of products.
Specifically, here’s what the FDA said their inspectors found:
1. Inadequate CAPA plan.
The company did not have appropriate statistical methodology in place to identify existing or potential causes of nonconforming product or other quality problems. In addition, the company did not have adequate effectiveness checks to assess that the root cause of a failure has been addressed and CAPA triggers were not followed.
2. Failure to ensure with a high degree of assurance that inspection and testing processes are valid.
The company had no documentation to demonstrate validation of the manufacturing process for a tip used with the Selector ultrasound aspiration device. The company performed hourly inspections and functional tests but full verification of dimensional measurements were not performed.
3. Inadequate procedures for quality audits.
The company’s internal Quality Audits procedure states that the maximum close-out period related to nonconformances found during internal audits is one calendar month. However the FDA found that several nonconformances had not been closed within the one calendar month timeframe. In addition, 7 out of 13 audits conducted in 2012 were not closed within the one calendar month timeframe.
4. Inadequate review of quality systems.
The company’s Quality Management Review procedure states that invited participants, if unable to attend the Quality Management Review Meeting, must send a designee in their place. However, there was no Customer Service representative, or a designee, at certain meetings. Additionally, there was no Production or Operations representative, or a designee, at a meeting held in December 2011.
The company’s management reports that it has provided detailed responses to the FDA as to its corrective actions on a monthly basis and, since the conclusion of the inspection, has undertaken significant efforts to remediate the observations. The Andover facility manufactures components of the CUSA ultrasonic aspirator system and intracranial pressure monitors. Sales of products manufactured in the Andover facility constituted less than 3% of Integra’s consolidated revenues in the 12 months ended September 30, 2012.
