Failure to submit medical device reports for its total parenteral nutrition bags landed the Metrix Company an eight-item Form 483 following a May 2016 inspection of its Dubuque, Iowa facility.
The firm manufactures on contract parenteral nutrition bags, transfusion filters and sets, IV bags and blood bags.
The company’s corrective action reports document two separate occasions that found that the compounding bags used for parenteral nutrition would not meet pumping accuracy with the high-speed compounder, the 483 says. The firm contacted a hospital customer and instructed them to scrap the bags, but it did not file a medical device report with the FDA nor did it report that a correction or removal was needed to reduce a health risk.
The Form 483 cites the firm for not establishing design review procedures. Specifically, an engineering validation test conducted in August 2014 noted that the new high-speed compounder failed the compounding accuracy specification when using certain compounding bags. A few months later the compounding unit was released to a customer for commercial use even though the beta testing failed.
In another example, the same compounding machine was tested in May 2015, and it also failed to meet compounding accuracy requirements. One month before that testing, three batches of bags were sold, but there was no documentation that these products passed the accuracy validation test before being released to the market.
The form also cited the firm for process validation failures and for not conducting a complete risk analysis.
The FDA said the test method for validating the compounding unit had not been validated, and there was no SOP documenting the test method. Moreover, there was no documentation showing that the test method was an accurate validation for the fluids that the hospital would be compounding.
The firm was also cited for not analyzing service reports, not establishing procedures for corrective and preventive actions and not establishing procedures to prevent contamination. The Metrix Company did not respond to a request for comment.
Read the Form 483 here: www.fdanews.com/09-07-16-Metrix483.pdf. — Tamra Sami