Westborough, Mass.-based Miach Orthopaedics, which designed the BEAR implant for ACL repairs, received a warning letter from the FDA following an inspection of the company’s facility.
The agency discovered violations including deficiencies across its sterilization and microbial control processes, design input and validation planning and supplier oversight, according to the Aug. 19 letter from the FDA.
Failure to fix the violations outlined in the letter could lead to the FDA taking regulatory action against Miach Orthopaedics, such as seizure, injunction and civil money penalties.
The FDA conducted its inspection from March 31 through April 23.
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