FDA Warns Biomedix, Cites Design Controls, CAPAs

Biomedix has received an FDA warning letter citing several design control failures with its manufacture of IV administration sets.

According to the June 14 letter, the Bloomington, Ind., company failed to establish procedures to ensure design requirements are met and did not maintain a design history file to document design changes. Biomedix also lacked procedures to document and validate changes before implementation.

An investigator from the Detroit district office found the company failed to establish adequate procedures for corrective and preventive actions as well. For instance, Biomedix documented scrapped components from an IV set manufacturing process between January 2010 and December 2012, but did not analyze or investigate the data to determine the cause or whether there were quality problems in the manufacturing process.

The company also did not evaluate scrapped components between January and December 2012 to determine if an investigation or notification of those responsible for the issues was needed.

Meanwhile, Biomedix uses a sterilization method for its sets, but has not validated the process to establish parameters that could consistently achieve the target sterility level. The devicemaker also has not validated the semiautomated processes used to produce the administration sets, the warning letter states.

Further, the investigator found the company had not established procedures for equipment settings used during manufacturing. And equipment settings in the production area were not consistent for similar pieces of equipment, the letter notes.

The FDA took Biomedix to task for quality oversight, noting its management responsibility procedure lacks provisions for management review. Management with executive responsibility has not reviewed the quality system at defined intervals and with enough frequency, the letter says. The company’s quality audit procedure sets a schedule for audits, but company officials said they had not conducted a quality audit since 2002.

Finally, Biomedix had not established quality requirements for suppliers or documented its supplier evaluations.

In-house design control processes aren’t the only items of concern: what about those of all of your suppliers, contractors or vendors? Learn to manage these risks with FDAnews’ The Insider’s Guide to Supplier Quality Success: FDA Device Experts Reveal Their Secrets. Order your copy without delay and get started on improving your brand.