The FDA has warned AG Industries on medical device reporting failures related to a complaint of a mini-nebulizer shocking a child and other good manufacturing practice violations.
The St. Louis manufacturer of respiratory replacement supplies failed to complete a Medical Device Report review and file an MDR on the complaint, according to the June 12 warning letter.
AG’s standard operating procedure requires it to evaluate complaints for reportability, but instead of an MDR review, the firm passed the complaint information on to the supplier and then failed to follow up, the letter says.
Process, Equipment Validation Lacking
The company also failed to validate certain equipment and its process for adding reground plastic scrap material to fresh resin when making plastic components. And AG lacked any specification for the rework of scrap plastic for use in device manufacturing, the letter notes.
The equipment validation issues related to a complaint about defective filters from July 2014, which prompted AG to modify and validate a welder. The validation used a certain sampling size, but there was no documented justification for reducing the sample size from the company’s SOP sampling plan, the letter says. Eleven samples failed the flange thickness measurement test, but AG changed the specification and tolerances of the part to match the measurement test results.
Another sampling issue related to a checklist in AG’s device history record. The checklist called for an acceptable quality limit sampling approach, with a certain AQL level for assembled devices. However, AG had no documented justification for a reduced AQL level and no documentation that it was even performing sampling according to the reduced AQL sampling, according to the letter.
AG also lacked documentation to show that nonconforming materials are reviewed and dispositioned. The company’s SOP says that nonconformances should be documented in a nonconformance report and identified with a “REJECT” tag, but, in practice, AG either reworks plastic product or throws out paper product without any investigation, the letter says.
Meanwhile, the devicemaker lacked procedures to ensure routine calibration, inspection and maintenance of equipment. AG has injection molding machines in its facility, but maintenance logs for three of them don’t include any calibration activities or inspections since the installation date.
The FDA also dinged AG’s handling of corrective and preventive actions. For example, a CAPA issued in December 2010 to address a Form 483 observation from the previous month was still open as of March 2015.
Another complaint, from April 2014, involved the mini-nebulizer that had shocked a child. As of March 2015, AG had not adequately completed steps of its customer complaint form for receipt of return product, complaint investigation and determination of corrective actions required.
In another case, the company initiated a CAPA and determined the root cause was an inadequate weld, but the investigation didn’t identify which lot numbers were included in the returned products and didn’t eliminate the possibility of failures found during quality investigation reports on finished goods before the complaint, the warning letter says.
Of 119 customer complaints received since Jan. 1, 2013, about 15 were still open during the inspection. The warning letter followed a March 23 to April 13 inspection by the FDA’s Kansas City district office.
AG Industries did not respond to a request for comment by press time.
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