About FDA
SMG 1313.7
FDA STAFF MANUAL GUIDES, VOLUME I - ORGANIZATIONS AND FUNCTIONS
FOOD AND DRUG ADMINISTRATION
OFFICE OF GLOBAL REGULATORY OPERATIONS AND POLICY
OFFICE OF REGULATORY AFFAIRS
OFFICE OF OPERATIONS
REGIONAL FIELD OFFICE, SOUTHEAST REGION, ATLANTA, GA
SOUTHEAST REGIONAL LABORATORY - ATLANTA, GA
Effective Date: 08/07/2012
1. SOUTHEAST REGIONAL LABORATORY - ATLANTA, GA (DLLRSC).
A. Plans, schedules, and controls Regional laboratory operations; and formulates, implements, and coordinates analytical workplans for Districts being served.
B. Performs laboratory analysis of samples for Florida, New Orleans, San Juan, and Atlanta Districts, and other FDA Districts, as requested to:
1. Assess each sample's compliance with applicable laws and regulations enforced by the Agency.
2. Determine the extent to which findings provide evidence of violative conditions and practices.
3. Obtain information through national surveillance programs for the purpose of identifying potential problems or trends.
C. Provides evidence regarding analytical findings as requested.
D. Conducts research to develop and refine methodology used in the analysis of samples and to explore new systems of analysis.
E. Performs laboratory analyses of samples for nutrient content for all Districts throughout the Agency's Regions in the United States in order to:
1. Assess each sample's compliance with applicable laws and regulations enforced by the Agency.
2. Obtain information through national surveillance programs for the purpose of identifying potential problems or trends.
F. Serves as the Regional resource in scientific knowledge and provides expert advice and training regarding laboratory techniques and technological developments to other Federal agencies, State and local agencies, foreign counterpart agencies, and industry.
G. Provides assistance to districts in the conduct of complex food and drug inspections requiring an in-depth knowledge of laboratory techniques and practices and potential causes of adulteration.
H. Implements an effective internal quality assurance program.
2. CHEMISTRY BRANCH I (DLLRSC1).
A. Performs laboratory analyses for filth and decomposition and examines samples of human and veterinary drug, biological, and medical devices collected by the Florida, New Orleans, San Juan, Atlanta, and other District Offices to assess each sample's compliance with applicable laws and regulations enforced by the Agency; and to assess the extent to which reconditioning, reprocessing, and relabeling actions have brought violative commodities into compliance.
B. Tests, for purposes of violation, methods submitted by industry as part of a New Drug Application or Abbreviated New Drug Application, and provides a report of evaluation and technical comments on any deficiencies found.
C. Conducts research to develop and refine methodology used in the analysis of drug, medical device, filth and decomposition samples which includes developing analytical methodology, developing sample and sample preparation procedures, analytical methods validation and collaborative studies, extension of existing analytical methods to additional commodities and exploring new systems of analysis.
D. Provides expert advice and training regarding laboratory techniques and technological developments to other Federal agencies; to State, local and foreign counterpart agencies, and to industry.
E. Provides court testimony regarding analytical findings as requested.
F. Plans, schedules, and controls Branch operations; and formulates, implements, and coordinates workplans for Districts serviced as these operations relate to the Branch.
G. Maintains liaison with scientists and scientific bodies with interests pertinent to laboratory activities.
H. Assists investigational staff in the conduct of inspections and investigations involving complex testing procedures and production processes which may result in adulterated drug and medical device products.
3. MICROBIOLOGY BRANCH (DLLRSC2).
A. Performs microbiological analyses of samples for the Florida, Atlanta, New Orleans, San Juan, and other District offices, as requested, in order to assess each sample's compliance with applicable laws and regulations enforced by the Agency.
B. Conducts research to develop and refine methodology used in the analyses of microbiological samples and to explore new techniques and systems of analysis.
C. Serves as a national resource in scientific knowledge, laboratory methodology, and techniques applicable to infant formula, medical foods, animal use, and sterility testing.
D. Provides court testimony regarding analytical findings, as requested.
E. Plans, schedules, and controls Branch operations; and formulates, implements, and coordinates workplans for Districts serviced as these operations relate to the Branch.
F. Maintains liaison with scientists and scientific bodies with interests pertinent to its particular scientific specialty.
G. Provides expert advice and training regarding laboratory techniques and technological developments to other Federal agencies; to State, local, and foreign counterpart agencies; and to industry.
H. Assists investigational staff in the conduct of inspections and investigations involving complex testing procedures and production processes which may result in microbiologically contaminated products.
4. ATLANTA CENTER FOR NUTRIENT ANALYSIS (DLLRSC3).
A. Serves as a national resource in scientific knowledge, laboratory methodology, and techniques applicable to solving Field problems pertinent to nutritional analyses.
B. Performs laboratory analyses of samples for all FDA Districts throughout the Agency's Regions in order to assess each sample's compliance with applicable laws and regulations enforced by the Agency.
C. Conducts research to develop, modify and/or validate methodology for the assay of nutrients in foods and to explore new systems and analyses.
D. Provides expert advice and training regarding laboratory techniques and technological developments to other Federal agencies; to State, local, and foreign counterpart agencies; and to industry.
E. Plans, schedules, and controls Center operations; implements and coordinates workplans for all Districts throughout the Agency's Regions, as these operations relate to nutrient analysis.
F. Provides court testimony regarding analytical findings as requested.
G. Maintains liaison with scientists and scientific bodies with interests pertinent to nutritional analyses.
5. CHEMISTRY BRANCH II (DLLRSC4).
A. Performs laboratory analyses and examination of food, feed and cosmetic samples collected by the Florida, New Orleans, San Juan, Atlanta, Cincinnati, Baltimore, and other District Offices to assess each each sample's compliance with applicable laws and regulations enforced by the Agency; to assess the extent to which reconditioning, reprocessing, and relabeling actions brought violative commodities into compliance.
B. Conducts research in a variety of aspects regarding food, and feed products; includes developing analytical methodology, developing sampling and sample preparation procedures, analytical methods validation and collaborative studies, extension of existing analytical methods to additional commodities and exploring new systems of analysis.
C. Provides expert advice and training regarding laboratory techniques and technological developments to other Federal agencies; to State, local and foreign counterpart agencies, and to industry.
D. Provides court testimony regarding analytical findings as requested.
E. Plans, schedules, and controls Branch operations; and formulates, implements, and coordinates workplans for Districts serviced as these operations relate to the Branch.
F. Maintains liaison with scientists and scientific bodies with interests pertinent to laboratory activities.
G. Conducts research on the analytical chemistry of natural toxins; which includes developing analytical methodology, developing sample and sample preparation procedures, analytical methods validation and collaborative studies, extension of existing analytical methods to additional commodities and exploring new systems of analysis.
6. AUTHORITY AND EFFECTIVE DATE.
The functional statements for this Laboratory were approved by the Commissioner of Food and Drugs, effective August 7, 2012.
