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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)
Rafael Arroyo
(301) 796-4839
Alicia Mozzachio
(301) 796 3206
Larry Ouderkirk
(301) 796-1585
Air Handling (HVAC)
Milva Melendez
(301) 396-0662
Tara Gooen
(301) 796-3257
Application Integrity Policy
Karen Takahashi
(301) 796-3191
Paula Katz
(301) 796-6972
Aseptic Processing
Brenda Uratani
(301) 796-3284
Diane Raccasi
(301) 796-3927
Maan Abduldayem
(301) 796-3916
Tamara Ely
(301) 796-5088
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
Rafael Arroyo
(301) 796-4839
Blend Uniformity
Vibhakar Shah
(301) 796-1750
Metitia Gramby
(301) 796-4238
Rafael Arroyo
(301) 796-4839
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, 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
Bo Chi (Biotech)
(301) 796-3190
Clinical Significance
Alicia Mozzachio
(301) 796-3206
Clinical Supplies/IND
Tamara Ely
(301) 796-5088
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
Continuous Manufacturing
Francis Godwin
(301) 796-5362
Tara Gooen
(301) 796-3257
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
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
 
 
 
Drug/Device 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 and Equipment (General)
Tara Gooen
(301) 796-3257
Milva Melendez
(301) 796-0662
Denise Digiulio
(610) 430-7864
Fermentation / Cell Culture
Patricia Hughes
(301) 796-3189
Bo Chi
(301) 796-3190
Tim Pohlhaus
(301) 796-5224
Mary Farbman
(301) 796-4171
Kalavati Suvarna
(301) 796-0821
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
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
Tara Gooen
(301) 796-3257
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
Donald Obenhuber
(301) 796-3214
Colleen Thomas
(301) 796-4853
Litigation Guidance and Support
Rosa Motta
(301) 796-3282
Lyophilization
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
Packaging, Repackaging, & Labeling Control
Victor (Ray) Gaines
(301) 796-9645
Hidee Molina
(301) 796-3195
Dacia Quick
(240) 402-5001
Parametric Release
Brenda Uratani
(301) 796-3252
Donald Obenhuber
(301) 796-3214
Pharmacies, CGMP
Ian Deveau
(301) 796-5061
Tamara Ely
(301) 796-5088
Positron Emission Tomography (PET)
Brenda Uratani
(301) 796-3252
Metitia Gramby
(301) 796-4238
Tamara Felton-Clark
(301) 796-4162
Krishna Ghosh
(301) 796-2644
Pre-Approval Inspections (BLA)
Patricia Hughes
(301) 796-3189
Pre-Approval Inspections (NDA/ANDA)
Tara Gooen
(301) 796-3257
Francis Godwin
(301) 796-5362
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
 
 
 
QC Responsibilities
Grace McNally
(301) 796-3286
Victor (Ray) Gaines
(301) 796-9645
Milva Melendez
(301) 796-0662
 
 
 
Quality Informatics
Mark Browning
(301) 796-5342
Reprocessing, Reworking & Salvaging
Tara Gooen
(301) 796-3257
 
 
 
Risk Assessment Methods
Rick Friedman
(301) 796-3268
 
 
 
Root Cause Analysis
Karthik Iyer
(301) 796-0441
Cesar Matto
(301) 796-5339
Metitia Gramby
(301) 796-4238
Scale-up/ Technology Transfer
Tara Gooen
(301) 796-3257
Milva Melendez
(301) 396-0662
Francis Godwin
(301) 796-5362
 
 
 
Solid Oral Drugs
Vibhakar Shah
(301) 796-1750
Karen Takahashi
(301) 796-3191
Metitia Gramby
(301) 796-4238
Milind Ganjawala
(301) 796-3318
Stability/Expiration Dates
Rafael Arroyo
(301) 796-4839
Vipul Dholakia
(301) 796-5065
Rosa Motta
(301) 796-3282
 
 
 
 
 
 
Statistics/Design of Experiment
Karthik Iyer
(301) 796-0441
Vibhakar Shah
(301) 796-1750
Francis Godwin
(301) 796-5362
Sterilization/Terminal
Brenda Uratani
(301) 796-3252
Donald Obenhuber
(301) 796-3214
Tara Gooen
(301) 796-3257
Maan Abduldayem
(301) 796-3916
 
 
 
Supply Chain
Paula Katz 
(301) 796-6972 
Denise Digiulio
(610) 430-7864
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
Tara Gooen
(301) 796-3257
Donald Obenhuber
(301) 796-3214
Tracie Sharp
(301) 796-3208

 
CDER Compliance Program Contacts
 Routine CGMP Inspections

Subject
Contact Name
Contact Phone
Contact Email
Drug Manufacturing Inspections (7356.002)
Brian Hasselbalch
(301) 796-3279
Sterile Drug Process Inspections (7356.002A)
Brenda Uratani
 
(301) 796-3284
 
Diane Raccasi
(301) 796-3927
 
Drug Repackers and Relabelers (7356.002B)
Victor (Ray) Gaines
(301) 796-9645
Radioactive Drugs (7356.002C)
Brenda Uratani
(301) 796-3284
Compressed Medical Gases (7356.002E)
Paul Haynie
(301) 796-3261
Milind Ganjawala
(301) 796-3318
Active Pharmaceutical Ingredients  (7356.002F)
Alicia Mozzachio
(301) 796-3206
Inspections of Licensed Biological Therapeutic Drug Products (7356.002M)
Patricia Hughes
(301) 796-3189
Positron Emission Tomography (7356.002P)
Brenda Uratani
(301) 796-3284
Postmarket Drug Product Surveys (Drug Quality Sampling and Testing) (7356.008A)
Andrea (Andy) Schaub
(301) 796-3225
Drug Quality Reporting System (DQRS) MedWatch/NDA FARs (7356.021A/B)
Elise Murphy
(301) 796-7565
Pre-approval Inspections (NDA/ANDA/BLA) (7346.832)
Tara Gooen
 
(301) 796-3257
Francis Godwin
(301) 796-5362