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A history of failing to submit medical device reports landed specification developer Circulatory Technology a third Form 483 for the firm’s Oyster Bay, New York, facility. Read More
Failure to control nonconforming products landed Dongguan Microview Medical a warning letter following an FDA inspection of its facility in Guangdong, China. Read More
The FDA issued warning to four devicemakers for lax design controls, inaccurate labeling and other serious failures at their manufacturing facilities. Read More
The FDA issued a warning letter to a devicemaker in Pest, Hungary for serious quality system failures, including inadequate design and process controls. Read More
The FDA slapped Thai condom manufacturer Okamoto Rubber Products with a warning letter after receiving an inadequate response to a 483 following an inspection of the firm’s Pathumthani site. Read More
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