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Electro-Cap Handed 483 for Validation Procedure Lapses

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