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Office of Global Regulatory Operations and Policy: Difference between revisions
Office of Global Regulatory Operations and Policy (view source)
Revision as of 22:19, 9 January 2025
, 9 January→Field laboratories
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The Office of Regulatory Affairs operates thirteen field laboratories. The field science laboratories were historically part of the FDA districts infrastructure but are now independent entities. ORA has five regional, six district, and two specialty laboratories such as the Forensic Chemistry Center (FCC) and the Winchester Engineering and Analytical Center (WEAC).<ref>{{cite web |url=https://www.fda.gov/ScienceResearch/FieldScience/ |title= U.S. FDA Field Science and Laboratories |website= U.S. FDA Science & Research |publisher=U.S. Food & Drug Administration}}</ref> | The Office of Regulatory Affairs operates thirteen field laboratories. The field science laboratories were historically part of the FDA districts infrastructure but are now independent entities. ORA has five regional, six district, and two specialty laboratories such as the Forensic Chemistry Center (FCC) and the Winchester Engineering and Analytical Center (WEAC).<ref>{{cite web |url=https://www.fda.gov/ScienceResearch/FieldScience/ |title= U.S. FDA Field Science and Laboratories |website= U.S. FDA Science & Research |publisher=U.S. Food & Drug Administration}}</ref> | ||
Below is the list of the 13 field laboratories operated by the Office of Regulatory Affairs (ORA): | |||
Regional Laboratories: | Regional Laboratories: | ||
* Northeast Regional Laboratory (NERL) - Jamaica, NY | * [[Northeast Regional Laboratory]] (NERL) - Jamaica, NY | ||
* Central Regional Laboratory (CRL) - Jefferson, AR | * [[Central Regional Laboratory]] (CRL) - Jefferson, AR | ||
* Southeast Regional Laboratory (SERL) - Atlanta, GA | * [[Southeast Regional Laboratory]] (SERL) - Atlanta, GA | ||
* Southwest Regional Laboratory (SWRL) - Dallas, TX | * [[Southwest Regional Laboratory]] (SWRL) - Dallas, TX | ||
* Pacific Regional Laboratory Northwest (PRL-NW) - Bothell, WA | * [[Pacific Regional Laboratory Northwest]] (PRL-NW) - Bothell, WA | ||
District Laboratories: | District Laboratories: | ||
* | * [[Pacific Regional Laboratory Southwest]] (PRL-SW) - Irvine, CA | ||
* | * [[Mid-Atlantic Laboratory]] (MAL) - Winchester, VA | ||
* | * [[New England Laboratory]] (NEL) - Bedford, MA | ||
* | * [[Orlando Laboratory]] (ORDL) - Orlando, FL | ||
* | * [[San Francisco Laboratory]] (SFL) - Alameda, CA | ||
* | * [[Kansas City Laboratory]] (KCL) - Lenexa, KS | ||
Specialty Laboratories: | Specialty Laboratories: | ||
* | * [[Forensic Chemistry Center]] (FCC) - Cincinnati, OH | ||
* | * [[Winchester Engineering and Analytical Center]] (WEAC) - Winchester, MA | ||
== Manuals == | == Manuals == | ||
ORA operations are generally conducted according to the: | ORA operations are generally conducted according to the: | ||
* | * Compliance Program Guidance Manual (CPGM),<ref>{{cite web |url=https://www.fda.gov/ICECI/ComplianceManuals/ComplianceProgramManual/ |title= U.S. FDA Compliance Program Guidance Manual |website= U.S. FDA Inspections, Compliance, Enforcement, and Criminal Investigations |publisher=U.S. Food & Drug Administration}}</ref> | ||
* | * Investigations Operations Manual (IOM),<ref>{{cite web |url=https://www.fda.gov/ICECI/Inspections/IOM/ |title= U.S. FDA Investigations Operations Manual |website= U.S. FDA Inspections, Compliance, Enforcement, and Criminal Investigations |publisher=U.S. Food & Drug Administration}}</ref> | ||
* | * Regulatory Procedures Manual (RPM).<ref>{{cite web |url=https://www.fda.gov/ICECI/ComplianceManuals/RegulatoryProceduresManual/ |title= U.S. FDA Regulatory Procedures Manual |website= U.S. FDA Inspections, Compliance, Enforcement, and Criminal Investigations |publisher=U.S. Food & Drug Administration}}</ref> | ||
==Related== | ==Related== | ||