Device contract manufacturer Minnesota MedTec was found to be lax in training its production staff and handling customer complaints, according to a Form 483 received following an inspection of the firm’s Maple Grove, Minnesota facility. Read More

Inadequate corrective and preventive actions were a repeat observation that came up in an inspection of Keystone Manufacturing’s Kalamazoo, Michigan facility. Read More

Contract manufacturer Paragon Manufacturing of Everett, Washington had not established adequate procedures for acceptance of incoming products, and procedures were not in place to control product that did not conform to specifications, an FDA inspection revealed. Read More

With the FDA’s foreign inspections on hold through April due to the coronavirus outbreak, the agency is doing “anything and everything” to make use of international regulators to keep inspections going, according to a senior agency official. Read More

Failure to establish corrective and preventive actions procedures and systems for receiving, reviewing and evaluating complaints landed devicemaker Oxus a 483 following an inspection of its Auburn Hills, Michigan facility. Read More

Biomedix WAI’s process validation procedures didn’t ensure that products would consistently meet specifications, an FDA inspection of the firm’s Bloomington, Indiana facility found. Read More

Failure to maintain complaints and submit medical device reports to the FDA, among other serious quality failures, landed devicemaker Ortho Solutions DBA DynaFlex a Form 483 following an FDA inspection of its Saint Ann, Missouri plant. Read More

Rhode Island device manufacturer Unetixs Vascular drew an FDA warning letter for failing to meet design requirements for its MultiLab Series ROODRA vascular diagnostic system. Read More