About FDA
SMG 1311.6
FDA STAFF MANUAL GUIDES, VOLUME I - ORGANIZATIONS AND FUNCTIONS
FOOD AND DRUG ADMINISTRATION
OFFICE OF REGULATORY AFFAIRS
REGIONAL OPERATIONS
REGIONAL FIELD OFFICE, NORTHEAST REGION - JAMAICA, NY
NORTHEAST REGIONAL LABORATORY - JAMAICA, NY
Effective Date: 08/07/2012
1. NORTHEAST REGIONAL LABORATORY - JAMAICA, NY (DLLRNB).
A. Plans, schedules, and controls Regional laboratory operations; and formulates, implements, and coordinates domestic and import analytical workplans and schedules with district offices being serviced.
B. Maintains an effective internal quality assurance program (17025 accredited).
C. Conducts laboratory testing and analysis of samples for FDA District Offices, as requested, to:
1. Assess their compliance with applicable laws and regulations enforced by the Agency;
2. Determine the extent to which findings provide evidence of violative conditions and practices; and
3. Obtain information through national surveillance programs for the purpose of identifying potential problems or trends.
D. Provides evidence regarding analytical findings as requested.
E. Conducts research and participate in collaborative studies to develop and refine methodology used in the analysis of samples and to explore new systems of analysis.
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, academia, and industry.
G. Provides assistance to districts in the Region 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. Serves as a national resource for analyses requiring mass spectroscopic instrumentation, as well as food chemistry, drug chemistry, and microbiological analyses.
I. Maintains liaison with scientists and scientific bodies with interests pertinent to laboratory activities.
2. MICROBIOLOGICAL SCIENCES BRANCH (DBRNB1).
A. Performs microbiological analyses of samples for district offices, as assigned by the National Sample Distributor or as directed by assignments, in order to assess each sample's compliance with applicable laws and regulations enforced by the Agency and if applicable, to assess the extent to which reconditioning, reprocessing, and relabeling actions have brought violative commodities into compliance.
B. Conducts research and participate in collaborative studies to develop and refine methodology used in the analysis of microbiological samples and to explore new techniques and 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, academia, and industry.
D. Provides court testimony regarding analytical findings, as requested.
E. Serves as a Regional resource in scientific knowledge, laboratory methodology, and techniques applicable to solving field problems pertinent to microbiological analyses.
F. Assists investigational staff in the conduct of inspections and investigations involving complex testing procedures and production processes which may result in microbiologically contaminated products.
G. Maintains liaison with scientists and scientific institutions with interest pertinent to their respective scientific specialties.
H. Maintains an effective internal quality assurance program (17025 accredited).
I. Plans, schedules, and manages Branch operations; and formulates, implements, and coordinates workplans with district offices served.
J. Conducts research in a variety of aspects regarding microbiological concerns.
3. CHEMISTRY BRANCH I (DLLRNB2).
A. Performs laboratory analyses and examination of food and drug samples. These samples, which are collected by district offices and assigned to the laboratory, are analyzed to assess each sample's compliance with laws and regulations enforced by the Agency; and if applicable, 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. Maintains an effective internal quality assurance program (17025 accredited).
D. Conducts research and participate in collaborative studies to develop and refine methodology used in the analysis of food, feed, and drug samples and to explore new techniques and systems of analysis.
E. 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.
F. Provides expert advice and training regarding laboratory techniques and technological developments to other Federal agencies; to State, local and foreign counterpart agencies, academia, and industry.
G. Provides court testimony regarding analytical findings as requested.
H. Plans, schedules, and controls Branch operations; and formulates, implements, and coordinates workplans for district offices served.
I. Assists investigational staff in the conduct of inspections and investigations involving complex testing procedures and production processes which may result in adulterated food, feed, and cosmetic products.
J. Maintains liaison with scientists and scientific institutions, with interest pertinent to laboratory activities.
K. Conducts research in a variety of aspects regarding food and drug samples.
4. CHEMISTRY BRANCH II (DLLRNB3).
A. Performs laboratory analyses and examination of food and drug samples. These samples, which are collected by district offices and assigned by the National Sample Distributor, are analyzed to assess each sample's compliance with laws and regulations enforced by the Agency; and if applicable, 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. Maintains an effective internal quality assurance program (17025 accredited).
D. Conducts research and participate in collaborative studies to develop and refine methodology used in the analysis of food , feed, and drug samples and to explore new techniques and systems of analysis.
E. Provides expert advice and training regarding laboratory techniques and technological developments to other Federal agency officials; to State, local, and foreign counterpart agencies officials, and to industry.
F. Provides court testimony regarding analytical findings as requested.
G. Plans, schedules, and manages Branch operations; and formulates, implements, and coordinates workplans with District Offices served.
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.
I. Assists investigational staff in the conduct of inspections and investigations involving complex testing procedures and production processes which may result in adulterated food, feed, and cosmetic products.
J. Maintains liaison with scientists and scientific institutions with interests pertinent to laboratory activities.
K. Conducts research in a variety of aspects regarding food and feed products.
5. AUTHORITY AND EFFECTIVE DATE.
The functional statements for this District Office were approved by the Commissioner of Food and Drugs, effective August 7, 2012.
