www.fdanews.com/articles/126391-frantz-medical-gets-483-with-four-observations
Frantz Medical Gets 483 With Four Observations
April 21, 2010
Frantz
Medical Development received four observations in a Form 483 issued by the FDA last October following an inspection of the Mentor, Ohio, facility. The
FDA investigator found that the company has no objective way to monitor its suppliers. The approved vendor list indicates that “a pattern of
unsatisfactory performance requires action to be taken,” but it does not indicate how to measure unsatisfactory performance or what triggers further
action, the 483 says.
The GMP Letter
The GMP Letter