The FDA has warned the UK branch of GVS Filter Technology for failures in product-testing and quality control.
The Bologna, Italy-based company has branches worldwide and manufactures air and liquid filters for medical devices such as anesthesia machines and nebulizers.
Quality control failures cited in the Jan. 23 letter included three cases where nonconforming products required reworking and re-evaluation, but device history records did not document that the work was performed.
The FDA said the company’s quality control procedure doesn’t describe requirements for documenting how nonconforming products are handled, and doesn’t require documentation of justification and approval for use of nonconforming products.
The letter said five nonconformance reports didn’t adequately document disposition of nonconforming products. Records showed discrepancies in the number of devices determined to be “scrap” or for “use-as-is.”
Following inspection, GVS Filter updated its nonconformance procedure to document disposal actions. But the company’s response didn’t include corrections to faulty nonconformance reports or evidence that records created before the update were reviewed, the letter states.
FDA also criticized the company for process validation failures. A test report listed a batch of sample filters as “pass” after they failed to meet the specification of 99.97 percent. In another instance, a sampling plan for sodium-chloride efficiency testing was described with no documentation of the statistical technique used to verify product characteristics.
Although the company later updated its lot history record forms, it didn’t show evidence of retrospective review of other lot history records to determine that all acceptance tests were conducted properly. It also didn’t analyze “the potential risks to safety and effectiveness of the filters” that might result from deficient tests that weren’t recorded.
The company’s CAPA violations include failure to adequately document all corrective activities.
FDA noted two CAPA records for customer complaints and three nonconformance related CAPAs. It said the company didn’t document validation of the corrective actions to ensure that these actions didn’t adversely affect the devices in question.
The company is actively working to address all topics in the warning letter and is committed to providing the highest quality products in compliance with FDA regulations, a spokesman told IDDM.