GMP violations for blood bank lack of validation data.An FDA FDA
Food and Drug Administration
n.pr See Food and Drug Administration.
n.pr the abbreviation for the Food and Drug Administration. inspector documented several GMP GMP (guanosine monophosphate): see guanine. violations in a May 7 warning letter for Our Lady of the Lake Hospital, New Orleans New Orleans (ôr`lēənz –lənz, ôrlēnz`), city (2006 pop. 187,525), coextensive with Orleans parish, SE La., between the Mississippi River and Lake Pontchartrain, 107 mi (172 km) by water from the river mouth; founded , LA, including failure to perform a thorough investigation and make a record of the conclusions and follow-up of unexplained discrepancies. Also, the facility did not have any validation data to support the current testing of non-citrate anti-coagulated blood samples.
During an inspection of the hospital blood bank on March 30 and April 2, 5-8, the agency noted the blood bank did not have records to document that blood/blood components from the donations were quarantined quar·an·tine
a. A period of time during which a vehicle, person, or material suspected of carrying a contagious disease is detained at a port of entry under enforced isolation to prevent disease from entering a country. pending determination of donor suitability.
Moreover, records were not maintained with each significant step in the collection and processing of each unit of blood and blood components. Doc. 13052W