A complete response letter (CRL) from the FDA delays a product's entry to the market by an average of 14 months. Companies that receive the letters take an average of seven months just to respond to them. Imagine how much you could save if you could anticipate the FDA's concerns and address them before the agency issues the complete response letter? Now you can.
The FDA’s Cincinnati District Office issued a Form 483 to a maker of electroencephalogram application caps and related supplies due to missing validation and control procedures at its Eaton, Ohio, plant. The Form 483 lists three deviations investigators found during a Nov. 21 – 29, 2011, inspection of Electro-Cap International’s manufacturing plant and closely mirrors lapses noted in a July 2011 FDA warning letter to the company. The GMP Letter