Company: Cardinal Enterprises Inc.
Date: 12/07/2001
Product: Drug products
Master production and control records are not prepared, dated, and signed by one person with a full handwritten signature and independently checked, dated and signed by a second person. Master production records are generated from a computer as electronic records without any apparent controls to assure authenticity and integrity [21 CFR 211.186(a)-Form FDA Observation 21].
FDA District: New England District Office
