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Repackager and relabeler 180 Innovations failed to establish procedures for receiving, reviewing and evaluating complaints or for rework of nonconforming product, according to a Form 483 the firm received following an inspection of its Lakewood, Colorado plant. Read More
Failure to maintain and implement written medical device reporting procedures, complaint handling procedures and procedures for controlling nonconforming products were among the quality system failures uncovered during an FDA inspection of Neuromonics’ Westminster, Colorado facility. Read More
Failure to implement procedures for corrective and preventive actions (CAPAs) and to ensure the accuracy of test/measurement equipment coupled with missing documentation for device history records landed Northwest Eye Design a 483 following an inspection of its Kirkland, Washington facility. Read More
The UK’s Medicines and Healthcare products Regulatory Agency is warning that certificates are being issued by certification bodies titled “certificates or compliance,” or “attestation of compliance,” that have no legal standing under the UK’s medical device regulations. Read More
Centurion Medical Products received an FDA warning letter for selling unapproved combination test kits following FDA inspections at the firm’s Howell, Michigan facility Aug. 5-20, 2019, and its Williamston, Michigan facility Oct. 21 to Nov. 1, 2019. Read More
The FDA issued a warning letter to Modern Allergy Management doing business as Direct Med Solutions in Milton, Florida for selling COVID-19 test kits for at-home use. The test kits are considered adulterated and misbranded products, the agency said. Read More