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U.S. Department of Health and Human Services

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Office of Manufacturing and Product Quality: CGMP Subject Matter Contacts

 

 

Subject Contacts

Subject
Contact Name
Contact Phone
Contact Email
Active Pharmaceutical Ingredients (API)
Alicia Mozzachio
(301) 796 3206
Rafael Arroyo
(301) 796-4839
Larry Ouderkirk
(301) 796-1585
Joseph Duran
(301) 796-0491
Air Handling (HVAC)
Milva Melendez
(301) 796-0662
Regina Brown
(301) 796-3196
David Jones
(301) 796-3759
Aseptic Processing
Maan Abduldayem
(301) 796-3916
Diane Raccasi
(301) 796-3927
Tamara Ely
(301) 796-5088
Rafael Arroyo
(301) 796-4839
Tamara Felton-Clark
(301) 796-4162
Biotechnology Products & Facility Reviews
Patricia Hughes
(301) 796-3189
Kalavati Suvarna
(301) 796-0821
Bo Chi
(301) 796-3190
Tim Pohlhaus
(301) 796 5224
Mary Farbman
(301) 796-4171
Blend Uniformity
Vibhakar Shah
(301) 796-1750
Metitia Gramby
(301) 796-4238
Rafael Arroyo
(301) 796-4839
Mahesh Ramanadham
(301) 796-3272
Tamara Ely
(301) 796-5088
Botanical Manufacturing
Brian Hasselbalch
(301) 796-3279
Bovine Spongiform Encephalopathy
Diane Raccasi
(301) 796-3927
Colleen Thomas
(301) 796-4853
Case Development/Human Drug CGMPs
Teddi Lopez
(301) 796-3255
Carmelo Rosa
(301) 796-3667
Cleaning Validation
Tamara Ely
(301) 796-5088
Alicia Mozzachio
(301) 796-3206
Hidee Molina
(301) 796-3195
Mary Davis-Lopez
(301) 796-8859
Bo Chi (Biotech)
(301) 796-3190
Clinical Significance
Alicia Mozzachio
(301) 796-3206
Cindy Cho
(301) 796-1673
Andrew Brown
(301) 796-5361 
Mahesh Ramanadham
(301) 796-3272
Clinical Supplies/IND
Tamara Ely
(301) 796-5088
Deborah Parris
(240) 402-4284
Cold-Chain Management
Vipul Dholakia
(301) 796-5065
Peter Zhihao Qiu
(301) 796-6655
Computer System Validation
Steve Hertz
(301) 796-3203
David Doleski
(301) 796-2627
Krishnakali Ghosh
(301) 796-2644
Tsedenia Woldehanna
(301) 796-3197
Continuous Manufacturing
Vibhakar Shah
(301) 796-1750
Francis Godwin
(301) 796-5362
Mary Farbman
(301) 796-4171
Contract Manufacturing
Paula Katz
(301) 796-6972
Tamara Ely
(301) 796-5088
Rosa Motta
(301) 796-3282 
Victor (Ray) Gaines
(301) 796-9645
Corrective Action/Preventive Action
Francis Godwin
(301) 796-5362
Regina Brown
(301) 796-3196
Metitia Gramby
(301) 796-4238
Cesar Matto
(301) 796-5339
Cross Contamination (Penicillin & other potent compounds)
Diane Raccasi
(301) 796-3927
Cesar Matto
(301) 796-5339
Mary Farbman
(301) 796-4171
Data Integrity
Karen Takahashi
(301) 796-3191
Paula Katz
(301) 796-6972
Regina Brown
(301) 796-3196
Maan Abduldayem
(301) 796-3916
Drug/Device Combination Products (e.g., Metered-Dose Inhalers, Drug Coated Stents)
Vibhakar Shah
(301) 796-1750
Steve Hertz
(301) 796-3203
Grace McNally
(301) 796-3286
Juandria Williams
(301) 796-4196
Establishment Evaluation Systems & Requests (EES)
Marisa Stock-Heayn
(301) 796-4753
Rokhsana Safaai-Jazi
(301) 796-4463
Beth Philpy
(301) 796-3334
Electronic Records / Signatures
Steve Hertz
(301) 796-3203
David Doleski
(301) 796-2627
Endotoxins / Pyrogens
Mary Farbman
(301) 796-4171
Donald Obenhuber
(301) 796-3214
Bo Chi
(301) 796-3190
Diane Raccasi
(301) 796-3927
Excipients
Larry Ouderkirk
(301) 796-1585
Vibhakar Shah
(301) 796-1750
Expert Witness
Rosa Motta
(301) 796-3282
Brian Hasselbalch
(301) 796-3279
Tamara Felton-Clark
(301) 796-4162
Facilities Design and Equipment
Denise Digiulio
(610) 430-7864
Milva Melendez
(301) 796-0662
Michael Shanks
(240) 402-4613
Donald Obenhuber
(301) 796-3214
Fermentation / Cell Culture
Bo Chi
(301) 796-3190
Tim Pohlhaus
(301) 796-5224
Mary Farbman
(301) 796-4171
Rafael Arroyo
(301) 796-4839
Foreign Inspections
Carmelo Rosa
(301) 796-3667
Beth Philpy
(301) 796-3334
Marisa Stock-Heayn
(301) 796-4753
Alicia Mozzachio
 (301) 796-3206
Homeopathy
Tamara Ely
(301) 796-5088
Christina Alemu-Cruickshank
(301) 796-3192
Impurities
Larry Ouderkirk
(301) 796-1585
Linda Ng
(301) 796-1426
Mary Farbman
(301) 796-4171
International CGMP Issues and Agreements
Karen Takahashi
(301) 796-3191
Helen Saccone
(301) 796-4758
Isolator Technology
Rick Friedman
(301) 796-3268
Laboratory (Chemistry)
Paul Haynie
(301) 796-3261
Allison Aldridge
(301) 796-0483
Donald Lech
(301) 796-4166
Linda Ng
(301) 796-1426
Rafael Arroyo
(301) 796-4839
Concepcion Cruz
(301) 796-3254
Mary Farbman
(301) 796-4171
Laboratory (Microbiology)
Diane Raccasi
(301) 796-3927
Larry Ouderkirk
(301) 796-1585
Bo Chi
(301) 796-3190
Cesar Matto
(301) 796-5339
Litigation Guidance and Support
Rosa Motta
(301) 796-3282
Lyophilization
Robert Wittorf
(240) 402-3113
Rafael Arroyo
(301) 796-4839
Colleen Thomas
(301) 796-4853
David Doleski
(301) 796-2627
Medical Gases
Paul Haynie
(301) 796-3261
Milind Ganjawala
(301) 796-3318
Larry Ouderkirk
(301) 796-1585
 
Nanotechnology
Donald Lech
(301) 796-4166
Vibhakar Shah 
(301) 796-1750
Juandria Williams
(301) 796-4196
Oral Suspensions
Vipul Dholakia
(301) 796-5065
Out-of-Specification
Paul Haynie
(301) 796-3261
Hidee Molina
(301) 796-3195
Regina Brown
(301) 796-3196
Xiaohui (Sherry) Shen
(240) 402-4179
Packaging, Repackaging, & Labeling Control
Victor (Ray) Gaines
(301) 796-9645
Ebern Dobbin
(240) 402-4266
Hidee Molina
(301) 796-3195
Dacia Quick
(240) 402-5001
Pharmacy Compounding/Outsourcing Facilities
Ian Deveau
(301) 796-5061
Tamara Ely
(301) 796-5088
Positron Emission Tomography (PET)
Krishnakali Ghosh
(301) 796-2644
Metitia Gramby
(301) 796-4238
Tamara Felton-Clark
(301) 796-4162
Process Analytical Technology (PAT)
Vibhakar Shah
(301) 796-1750
Patricia Hughes
(301) 796 -3189
Steve Hertz
(301) 796-3203
Rafael Arroyo
(301) 796-4839
Process Validation, General
Grace McNally
(301) 796-3286
Tamara Felton-Clark
(301) 796-4162
Steve Hertz
(301) 796-3203
Regina Brown
(301) 796-3196
Quality Control Responsibilities
Grace McNally
(301) 796-3286
Victor (Ray) Gaines
(301) 796-9645
Milva Melendez
(301) 796-0662
Reprocessing/Reworking/Salvaging
Alicia Mozzachio
(301) 796-3206
Rafael Arroyo
(301) 796-4839
Scale-up/Technology Transfer
Rebecca Frey-Cooper
(240) 402-4127
Milva Melendez
(301) 396-0662
Francis Godwin
(301) 796-5362
Stability/Expiration Dates
Rafael Arroyo
(301) 796-4839
Vipul Dholakia
(301) 796-5065
Rebecca Frey-Cooper
(240) 402-4127
Statistics/Design of Experiment/Sampling
Karthik Iyer
(301) 796-0441
Vibhakar Shah
(301) 796-1750
Francis Godwin
(301) 796-5362
Sterilization/Terminal/Parametric Release
Maan Abduldayem
(301) 796-3916
Diane Raccasi
(301) 796-3927
Rafael Arroyo
(301) 796-4839
Donald Obenhuber
(301) 796-3214
Supply Chain/Incoming Materials & Control Strategy
Paula Katz 
(301) 796-6972 
Denise Digiulio
(610) 430-7864
Victor (Ray) Gaines
(301) 796-9645
Tamper-Evident Packaging
Diane Raccasi
(301) 796-3927
Topical Drugs
Alicia Mozzachio 
(301) 796-3206
Vibhakar Shah
(301) 796-1750
David Jones
(301) 796-3759
Transdermals
Steve Hertz 
(301) 796-3203
Juandria Williams
(301) 796-4196
Water Quality
Donald Obenhuber
(301) 796-3214
Tracie Sharp
(301) 796-3208

 
CDER Compliance Program Contacts
 Routine CGMP Inspections
SubjectContact NameContact PhoneContact Email
Drug Manufacturing Inspections (7356.002)Grace McNally(301) 796-3286grace.mcnally@fda.hhs.gov
Sterile Drug Process Inspections (7356.002A)Maan Abduldayem(301) 796-3916maan.abduldayem@fda.hhs.gov
Drug Repackers and Relabelers (7356.002B)Victor (Ray) Gaines(301) 796-9645victor.gaines@fda.hhs.gov
Radioactive Drugs
(7356.002C)
Paula Katz(301) 796-6972 Paula.Katz@fda.hhs.gov 
Compressed Medical Gases
(7356.002E)
Paul Haynie(301) 796-3261paul.haynie@fda.hhs.gov
Active Pharmaceutical Ingredients (7356.002F)Alicia Mozzachio(301) 796-3206alicia.mozzachio@fda.hhs.gov
Inspections of Licensed Biological Therapeutic Drug Products
(7356.002M)
Timothy Pohlhaus(301) 796-5224tim.pohlhaus@fda.hhs.gov
Positron Emission Tomography (7356.002P)Krishnakali Ghosh(301) 796-2644krishnakali.ghosh@fda.hhs.gov
Postmarket Drug Product Surveys (Drug Quality Sampling and Testing) (7356.008A)Andrea (Andy) Schaub(301) 796-3225andrea.schaub@fda.hhs.gov
Drug Quality Reporting System (DQRS) MedWatch/NDA FARs
(7356.021A/B)
Elise Murphy(301) 796-7565elise.murphy@fda.hhs.gov
Pre-approval Inspections
(7346.832) for NDA
Mahesh Ramanadham(301) 796-3272mahesh.ramanadham@fda.hhs.gov
Pre-approval Inspections
(7346.832) for ANDA
Francis Godwin(301) 796-5362francis.godwin@fda.hhs.gov
Pre-approval Inspections
(7346.832) for BLA
Timothy Pohlhaus(301) 796-5224tim.pohlhaus@fda.hhs.gov
Post Approval Inspection
(7356.843)
Mahesh Ramanadham(301) 796-3272mahesh.ramanadham@fda.hhs.gov