Day

October 1, 2001
Company: Grand RapidsDate: 10/1/01 Product: Thumper cardiopulmonary resuscitator Your response to FDA-483 point #6 regarding 21 CFR Part 11 – Electronic Records is not adequate as explained in more detail below. 21 CFR Part 11 During the FDA inspection it was discovered that electronic records are used to establish the firm’s Complaint Files, 21 CFR...
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