ORA laboratory manual

Sample collection and laboratory analysis is an important and critical part of FDA's regulatory activities. A valid sample is the starting point for most administrative and legal actions. Therefore, as evidence, the sample must be suitable to support FDA's charge that there has been a violation of the Act. The Laboratory Manual (LM) is the primary source for communicating to our laboratory staff the manner in which business is to be conducted within a regulatory framework while carrying out the agency's public health mission. It provides the standard against which work products should be measured and spells out the laboratory objectives for ISO 17025 accreditation.