Category: Device 483s
Inspection date range: 4/18/11-4/28/11
Company: Electro-Cap International, Inc.
1011 W. Lexington Rd.
Eaton, OH 45320
Inspector(s): Brigitte K. Hofmann
Observations: Your firm has introduced or delivered for introduction into interstate commerce a device that has been significantly changed or modified in materials and chemical composition without submitting a premarket notification to FDA, as required by 21 CFR 807.81(a)(3).