Company: Hunterdon Medical Center
Product: Biologics/Blood
Date: 5/3/04
Failure to maintain accurate records which identify unsuitable donors so that products from such individuals will not be distributed, as required by 21 CFR 606.160(e). For example, in June 2003, it was discovered that all donor cards from the year 2000 were inadvertently destroyed. Without the original donor record, there is no assurance that all deferred donors from that year were appropriately entered into your computerized donor system.
Failure to submit a biological product deviation report within 45 days from the date you acquired information suggesting that a reportable event occurred, as required 21 CFR Part 606.171. For example, on 1/03/03 your staff discovered that unit _____was labeled with an incorrect expiration date of 1/30/03. The error was discovered on 1/03/03, the same date the unit was transfused. An investigation determined the numbers were transposed when entered into your computer system.
FDA District: New Jersey District Office
