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Home < Quality Assurance < FDA 483
Re: FDA Inspection conducted September 20-24, 2004 To Whom It May Concern: We are pleased to announce the results of the recent FDA cGMP inspection of our laboratory. Two inspectors, Caryn M. McNab and Tracey T. Duong both from Los Angeles District, spent four days reviewing records pertaining to an NDA while also performing a general cGMP compliance inspection. Four observations were made regarding the methods developed and validated for the NDA. No observations were made concerning general cGMP compliance. These observations must have been minor because within five days of completing the inspection, FDA recommended that our role in the NDA be approved. Click here for a pdf copy of the Form 483, our response, and the FDA approval letter (FDA 483). Please email your comments or questions regarding this inspection to jack.northington@bodycote.com. Also click here for the 2006 Inspection or our 2002 Inspection. |
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