Contract Manufacturer Cited for Procedural Issues
The FDA cited contract devicemaker Tecomet in a Form 483 for deficiencies at its Pennsauken, New Jersey facility, including a failure to follow procedures.
After inspecting the site from April 29-May 10, the agency found that the firm didn’t follow its processing procedures correctly. Four records noted devices at least three degrees Fahrenheit below the temperatures specified in the procedures.
The records showed that a class II component tension screw was distributed despite the company’s failure to follow procedures.