FDA flags 2 devicemakers’ compliance issues

The FDA has issued warning letters to two medical device manufacturers, LeMaitre Vascular and Miach Orthopaedics, citing serious violations of federal quality regulations following recent facility inspections. 

LeMaitre Vascular, based in Burlington, Mass., received a letter Aug. 11 after an FDA inspection of its North Brunswick, N.J., site; the agency found multiple violations related to its Artegraft Collagen Vascular Graft devices. The FDA cited the company for failures in water system contamination control, inadequate sterilant validation and insufficient environmental sterilization process monitoring. 

Inspectors found inconsistencies in water sampling procedures, lack of documentation verifying sanitization and inadequate assessment of the impact of a changed sterilant, the letter said. 

Miach Orthopaedics, based in Westborough, Mass., was issued a warning letter Aug. 19 following an inspection of its facility in March and April. The FDA flagged issues with the company’s sterilization validation and control processes for its Bridge-Enhanced ACL Restoration Implant. The agency found that the firm had discontinued use of necessary anaerobic culture media during sterility testing, despite evidence that harmful bacteria was detectable only with the method. 

The FDA concluded that the devicemakers’ responses did not adequately address the violations and that further correction actions and updates are required. 

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