Subject

Contact Name

Contact Phone

Contact Email

Active Pharmaceutical Ingredients (API)

Rafael Arroyo

(301) 796-4839

rafael.arroyo@fda.hhs.gov

Alicia Mozzachio

alicia.mozzachio@fda.hhs.gov

Larry Ouderkirk

(301) 796-1585

Larry.Ouderkirk@fda.hhs.gov

Air Handling (HVAC)

Milva Melendez

(301) 396-0662

Milva.Melendez@fda.hhs.gov

Douglas Campbell

(301) 796-3201

douglas.campbell@fda.hhs.gov

Tara Gooen

(301) 796-3257

tara.gooen@fda.hhs.gov

Application Integrity Policy

Karen Takahashi

(301) 796-3191

Karen.Takahashi@fda.hhs.gov

Shawn Gould

(301) 796-3759

Shawn.Gould@fda.hhs.gov

Paula Katz

(301) 796-6972

Paula.Katz@fda.hhs.gov

Aseptic Processing

Brenda Uratani

(301) 796-3284

Brenda.Uratani@fda.hhs.gov

Douglas Campbell

301-796-3927

Douglas.Campbell@fda.hhs.gov

Diane Raccasi

(301) 796-3927

Diane.Raccasi@fda.hhs.gov

Michelle Clark-Stuart

(301) 796-3197

Michelle.Clark-Stuart@fda.hhs.gov

Biotechnology Products & Facility Reviews

Patricia Hughes

(301) 796-3189

patricia.hughes@fda.hhs.gov

Kalavati Suvarna

(301) 796-0821

Kalavati.Suvarna@fda.hhs.gov

Bo Chi

(301) 796-3190

Bo.Chi@fda.hhs.gov

Rafael Arroyo

(301) 796-4839

Rafael.Arroyo@fda.hhs.gov

Blend Uniformity

Metitia Gramby

(301) 796-4238

Metitia.Gramby@fda.hhs.gov

Vibhakar Shah

(301) 796-1750

Vibhakar.Shah@fda.hhs.gov

Rafael Arroyo

(301) 796-4839

Rafael.Arroyo@fda.hhs.gov

Botanicals Manufacturing

Brian Hasselbalch

(301) 796-3279

Brian.Hasselbalch@fda.hhs.gov

Vibhakar Shah

(301) 796-1750

Vibhakar.Shah@fda.hhs.gov

Bovine Spongiform Encephalopathy

Diane Raccasi

(301) 796-3927

Diane.Raccasi@fda.hhs.gov

Colleen Thomas

(301) 796-4853

Colleen.Thomas@fda.hhs.gov

CGMP Case Development

Teddi Lopez

(301) 796-3255

teddi.lopez@fda.hhs.gov

Carmelo Rosa

(301) 796-3667

Carmelo.Rosa@fda.hhs.gov

Cleaning Validation

Tamara Ely

(301) 796-5088

Tamara.Ely@fda.hhs.gov

Alicia Mozzachio

alicia.mozzachio@fda.hhs.gov

Hidee Molina

(301) 796-3195

Hidee.Molina@fda.hhs.gov

Bo Chi (Biotech)

(301) 796-3190

Bo.Chi@fda.hhs.gov

Clinical Significance

Alicia Mozzachio

alicia.mozzachio@fda.hhs.gov

Clinical Supplies/IND

Tamara Ely

(301) 796-5088

Tamara.Ely@fda.hhs.gov

Zhong Li

(301) 796-1798

Zhong.Li@fda.hhs.gov

Cold-Chain Management

Rosa Motta

(301) 796-3282

rosa.motta@fda.hhs.gov

Vipul Dholakia

(301) 796-5065

vipul.dholakia@fda.hhs.gov

Computer Validation

April Inyard

(301) 796-5363

April.Inyard@fda.hhs.gov

Steve Hertz

(301) 796-3203

Steven.Hertz@fda.hhs.gov

David Doleski

(301) 796-2627

David.Doleski@fda.hhs.gov

Continuous Manufacturing

Francis Godwin

(301) 796-5362

francis.godwin@fda.hhs.gov

Tara Gooen

(301) 796-3257

tara.gooen@fda.hhs.gov

Contract Manufacturing

Victor (Ray) Gaines

(301) 796-9645

Victor.Gaines@fda.hhs.gov

Paula Katz

(301) 796-6972

Paula.Katz@fda.hhs.gov

Tamara Ely

(301) 796-5088

tamara.ely@fda.hhs.gov

Rosa Motta

(301) 796-3282

rosa.motta@fda.hhs.gov

Corrective Action/Preventive Action

Francis Godwin

(301) 796-5362

francis.godwin@fda.hhs.gov

Shawn Gould

(301) 796-3759

shawn.gould@fda.hhs.gov

Metitia Gramby

(301) 796-4238

metitia.gramby@fda.hhs.gov

Cross Contamination (Penicillin & other potent compounds)

Diane Raccasi

(301) 796-3927

Diane.Raccasi@fda.hhs.gov

Douglas Campbell

(301) 796-3201

douglas.campbell@fda.hhs.gov

Cesar Matto

(301) 796-5339

Cesar.Matto@fda.hhs.gov

Merideth Rose

(301) 796-1287

Merideth.Rose@fda.hhs.gov

Drug/Device Products (e.g., Metered-Dose Inhalers, Drug Coated Stents)

Vibhakar Shah

(301) 796-1750

Vibhakar.Shah@fda.hhs.gov

Brian Hasselbalch

(301) 796-3279

brian.hasselbalch@fda.hhs.gov

Steve Hertz

(301) 796-3203

Steven.Hertz@fda.hhs.gov

Grace McNally

(301) 796-3286

Grace.McNally@fda.hhs.gov

Establishment Evaluation Systems & Requests (EES)

Marisa Stock

(301) 796-4753

Marisa.Stock@fda.hhs.gov

April Inyard

(301) 796-5363

April.Inyard@fda.hhs.gov

Beth Philpy

(301) 796-3334

Elizabeth.Philpy@fda.hhs.gov

Electronic Records / Signatures

April Inyard

(301) 796-5363           

April.Inyard@fda.hhs.gov

Steve Hertz

(301) 796-3203

Steven.Hertz@fda.hhs.gov

David Doleski

(301) 796-2627

David.Doleski@fda.hhs.gov

Endotoxins / Pyrogens

Mary Farbman

(301) 796-4171

Mary.Farbman@fda.hhs.gov

Donald Obenhuber

(301) 796-3214

Donald.Obenhuber@fda.hhs.gov

Bo Chi

(301) 796-3190

Bo.Chi@fda.hhs.gov

Diane Raccasi

(301) 796-3927

Diane.Raccasi@fda.hhs.gov

Excipients

Larry Ouderkirk

(301) 796-1585

Larry.Ouderkirk@fda.hhs.gov

Vibhakar Shah

(301) 796-1750

vibhakar.shah@fda.hhs.gov

Steve Hertz

(301) 796-3203

Steven.Hertz@fda.hhs.gov

Expert Witness

Rosa Motta

(301) 796-3282

rosa.motta@fda.hhs.gov

Tamara Felton

(301) 796-4162

tamara.felton@fda.hhs.gov

Brian Hasselbalch

(301) 796-3279

Brian.Hasselbalch@fda.hhs.gov

Facilities and Equipment (General)

Tara Gooen

(301) 796-3257

tara.gooen@fda.hhs.gov

Douglas Campbell

(301) 796-3201

douglas.campbell@fda.hhs.gov

Denise Digiulio

(610) 430-7864

Denise.Digiulio@fda.hhs.gov

Steve Hertz

(301) 796-3203

steven.hertz@fda.hhs.gov

Fermentation / Cell Culture

Patricia Hughes

(301) 796-3189

patricia.hughes@fda.hhs.gov

Bo Chi

(301) 796-3190

bo.chi@fda.hhs.gov

Steve Hertz

(301) 796-3203

steven.hertz@fda.hhs.gov

Mary Farbman

(301) 796-4171

mary.farbman@fda.hhs.gov

Kalavati Suvarna

(301) 796-0821

kalavati.suvarna@fda.hhs.gov

Rafael Arroyo

(301) 796-4839

rafael.arroyo@fda.hhs.gov

Foreign Inspections

Carmelo Rosa

(301) 796-3667

carmelo.rosa@fda.hhs.gov

Beth Philpy

(301) 796-3334

elizabeth.Philpy@fda.hhs.gov

Marisa Stock

(301) 796-4753

marisa.stock@fda.hhs.gov

Alicia Mozzachio

alicia.mozzachio@fda.hhs.gov

Homeopathy

Tamara Ely

(301) 796-5088

tamara.ely@fda.hhs.gov

Impurities

Larry Ouderkirk

(301) 796-1585

larry.ouderkirk@fda.hhs.gov

Linda Ng

(301) 796-1426

Linda.Ng@fda.hhs.gov

Vibhakar Shah

(301) 796-1750

Vibhakar.Shah@fda.hhs.gov

Mary Farbman

(301) 796-4171

Mary.Farbman@fda.hhs.gov

International CGMP Issues and Agreements

Brian Hasselbalch

(301) 796-3279

brian.hasselbalch@fda.hhs.gov

Carmelo Rosa

(301) 796-3667

carmelo.rosa@fda.hhs.gov

Karen Takahashi

(301) 796-3191

Karen.Takahashi@fda.hhs.gov

Isolator Technology

Tara Gooen

(301) 796-3257

tara.gooen@fda.hhs.gov

Laboratory (Chemistry)

Paul Haynie

(301) 796-3261

paul.haynie@fda.hhs.gov

Allison Aldridge

(301) 796-0483

Allison.Aldridge@fda.hhs.gov

Donald Lech

(301) 796-4166

Donald.Lech@fda.hhs.gov

Linda Ng

(301) 796-1426

Linda.Ng@fda.hhs.gov

Rafael Arroyo

(301) 796-4839

Rafael.Arroyo@fda.hhs.gov

Concepcion Cruz

(301) 796-3254

Concepcion.Cruz@fda.hhs.gov

Vibhakar Shah

(301) 796-1750

Vibhakar.Shah@fda.hhs.gov

Mary Farbman

(301) 796-4171

Mary.Farbman@fda.hhs.gov

Laboratory (Microbiology)

Diane Raccasi

(301) 796-3927

diane.raccasi@fda.hhs.gov

Larry Ouderkirk

(301) 796-1585

Larry.Ouderkirk@fda.hhs.gov

Donald Obenhuber

(301) 796-3214

Donald.Obenhuber@fda.hhs.gov

Bo Chi

(301) 796-3190

Bo.Chi@fda.hhs.gov

Colleen Thomas

(301) 796-4853

Colleen.Thomas@fda.hhs.gov

Litigation Guidance and Support

Rosa Motta

(301) 796-3282

Rosa.Motta@fda.hhs.gov

Lyophilization

Rafael Arroyo

(301) 796-4839

rafael.arroyo@fda.hhs.gov

Colleen Thomas

(301) 796-4853

Colleen.Thomas@fda.hhs.gov

David Doleski

(301) 796-2627

David.doleski@fda.hhs.gov

Medical Gases

Paul Haynie

(301) 796-3261

paul.haynie@fda.hhs.gov

Larry Ouderkirk

(301) 796-1585

Larry.Ouderkirk@fda.hhs.gov

Milind Ganjawala

(301) 796-3318

Milind.Ganjawala@fda.hhs.gov

Nanotechnology

Donald Lech

(301) 796-4166

Donald.Lech@fda.hhs.gov

Vibhakar Shah

(301) 796-1750

Vibhakar.Shah@fda.hhs.gov

Oral Suspensions

Vipul Dholakia

(301) 796-5065

vipul.dholakia@fda.hhs.gov

Out-of-Specification

Paul Haynie

(301) 796-3261

paul.haynie@fda.hhs.gov

Hidee Molina

(301) 796-3195

Hide.Molina@fda.hhs.gov

Rafael Arroyo

(301) 796-4839

Rafael.Arroyo@fda.hhs.gov

Packaging, Repackaging, & Labeling Control

Tina Arowosegbe

(301) 796-4661

Celestina.Arowosegbe@fda.hhs.gov

Victor (Ray) Gaines

(301) 796-9645

Victor.Gaines@fda.hhs.gov

Hidee Molina

(301) 796-3195

Hide.Molina@fda.hhs.gov

Parametric Release

Brenda Uratani

(301) 796-3252

brenda.uratani@fda.hhs.gov

Donald Obenhuber

(301) 796-3214

Donald.Obenhuber@fda.hhs.gov

Pharmacies, CGMP

Tamara Ely

(301) 796-5088

Tamara.Ely@fda.hhs.gov

Positron Emission Tomography (PET)

Brenda Uratani

(301) 796-3252

brenda.uratani@fda.hhs.gov

Metitia Gramby

(301) 796-4238

Metitia.Gramby@fda.hhs.gov

Tamara Felton

(301) 796-4162

Tamara.Felton@fda.hhs.gov

Pre-Approval Inspections (BLA)

Patricia Hughes

(301) 796-3189

Patricia.Hughes@fda.hhs.gov

Pre-Approval Inspections (NDA/ANDA)

Concepcion Cruz

(301) 796-3254

concepcion.cruz@fda.hhs.gov

Tara Gooen

(301) 796-3257

tara.gooen@fda.hhs.gov

Process Analytical Technology (PAT)

Vibhakar Shah

(301) 796-1750

Vibhakar.Shah@fda.hhs.gov

Steve Hertz

(301) 796-3203

Steven.Hertz@fda.hhs.gov

Process Validation, General

Grace McNally

(301) 796-3286

grace.mcnally@fda.hhs.gov

Brian Hasselbalch

(301) 796-3279

brian.hasselbalch@fda.hhs.gov

Tamara Felton

(301) 796-4162

Tamara.Felton@fda.hhs.gov

Steve Hertz

(301) 796-3203

Steven.Hertz@fda.hhs.gov

Mary Farbman

(301) 796-4171

Mary.Farbman@fda.hhs.gov

QC Responsibilities

Grace McNally

(301) 796-3286

grace.mcnally@fda.hhs.gov

Victor (Ray) Gaines

(301) 796-9645

victor.gaines@fda.hhs.gov

Rafael Arroyo

(301) 796-4839

Rafael.Arroyo@fda.hhs.gov

Jennifer Stone

(301) 796-5361

Jennifer.Stone@fda.hhs.gov

Quality Informatics

Mark Browning

(301) 796-5342

mark.browning@fda.hhs.gov

Reprocessing, Reworking & Salvaging

Tara Gooen

(301) 796-3257

tara.gooen@fda.hhs.gov

Jennifer Stone

(301) 796-5361

Jennifer.Stone@fda.hhs.gov

Risk Assessment Methods

Brian Hasselbalch

(301) 796-3279

brian.hasselbalch@fda.hhs.gov

Rick Friedman

(301) 796-3268

Rick.Friedman@fda.hhs.gov

Root Cause Analysis

Karthik Iyer

(301) 796-0441

karthik.iyer@fda.hhs.gov

Cesar Matto

(301) 796-5339

Cesar.Matto@fda.hhs.gov

Metitia Gramby

(301) 796-4238

metitia.gramby@fda.hhs.gov

Scale-up/ Technology Transfer

Shawn Gould

(301) 796-3759

Shawn.Gould@fda.hhs.gov

Tara Gooen

(301) 796-3257

tara.gooen@fda.hhs.gov

Milva Melendez

(301) 396-0662

Milva.Melendez@fda.hhs.gov

Francis Godwin

(301) 796-5362

francis.godwin@fda.hhs.gov

Solid Oral Drugs

Vibhakar Shah

(301) 796-1750

Vibhakar.Shah@fda.hhs.gov

Karen Takahashi

(301) 796-3191

Karen.Takahashi@fda.hhs.gov

Metitia Gramby

(301) 796-4238

Metitia.Gramby@fda.hhs.gov

Milind Ganjawala

(301) 796-3318

Milind.Ganjawala@fda.hhs.gov

Stability/Expiration Dates

Rafael Arroyo

(301) 796-4839

Rafael.Arroyo@fda.hhs.gov

Zhong Li

(301) 796-1798

Zhong.Li@fda.hhs.gov

Vipul Dholakia

(301) 796-5065

vipul.dholakia@fda.hhs.gov

Vibhakar Shah

(301) 796-1750

Vibhakar.Shah@fda.hhs.gov

Rosa Motta

(301) 796-3282

Rosa.Motta@fda.hhs.gov

Statistics/Design of Experiment

Karthik Iyer

(301) 796-0441

karthik.iyer@fda.hhs.gov

Vibhakar Shah

(301) 796-1750

Vibhakar.Shah@fda.hhs.gov

Francis Godwin

(301) 796-5362

francis.godwin@fda.hhs.gov

Sterilization/Terminal

Brenda Uratani

(301) 796-3252

brenda.uratani@fda.hhs.gov

Donald Obenhuber

(301) 796-3214

Donald.Obenhuber@fda.hhs.gov

Tara Gooen

(301) 796-3257

tara.gooen@fda.hhs.gov

Maan Abduldayem

(301) 796-3916

Maan.Abduldayem@fda.hhs.gov

Douglas Campbell

(301) 796-3201

douglas.campbell@fda.hhs.gov

Supply Chain

Paula Katz

(301) 796-6972

Paula.Katz@fda.hhs.gov

Denise Digiulio

(610) 430-7864

Denise.Digiulio@fda.hhs.gov

Tamper-Evident Packaging

Diane Raccasi

(301) 796-3927

Diane.Raccasi@fda.hhs.gov

Topical Drugs

Alicia Mozzachio

alicia.mozzachio@fda.hhs.gov

Yanyan (Jenny) Quin

(301) 796-3207

yanyan.qin@fda.hhs.gov

Vibhakar Shah

(301) 796-1750

Vibhakar.Shah@fda.hhs.gov

Transdermals

Steve Hertz

(301) 796-3203

Steven.Hertz@fda.hhs.gov

Water Quality

Tara Gooen

(301) 796-3257

tara.gooen@fda.hhs.gov

Donald Obenhuber

(301) 796-3214

Donald.Obenhuber@fda.hhs.gov

Shawn Gould

(301) 796-3759

Shawn.Gould@fda.hhs.gov

Subject

Contact Name

Contact Phone

Contact Email

Drug Manufacturing Inspections (7356.002)

Brian Hasselbalch

(301) 796-3279

brian.hasselbalch@fda.hhs.gov

Sterile Drug Process Inspections (7356.002A)

Diane Raccasi

(301) 796-3927

diane.raccasi@fda.hhs.gov

Brenda Uratani

(301) 796-3284

brenda.uratani@fda.hhs.gov

Drug Repackers and Relabelers (7356.002B)

Tina Arowosegbe

(301) 796-4661

Celestina.Arowosegbe@fda.hhs.gov

Radioactive Drugs (7356.002C)

Brenda Uratani

(301) 796-3284

brenda.uratani@fda.hhs.gov

Compressed Medical Gases (7356.002E)

Paul Haynie

(301) 796-3261

paul.haynie@fda.hhs.gov

Milind Ganjawala

(301) 796-3318

Milind.Ganjawala@fda.hhs.gov

Active Pharmaceutical Ingredients  (7356.002F)

Alicia Mozzachio

alicia.mozzachio@fda.hhs.gov

Inspections of Licensed Biological Therapeutic Drug Products (7356.002M)

Patricia Hughes

(301) 796-3189

patricia.hughes@fda.hhs.gov

Positron Emission Tomography (7356.002P)

Brenda Uratani

(301) 796-3284

brenda.uratani@fda.hhs.gov

Postmarket Drug Product Surveys (Drug Quality Sampling and Testing) (7356.008A)

Andrea (Andy) Schaub

(301) 796-3225

andrea.schaub@fda.hhs.gov

Drug Quality Reporting System (DQRS) MedWatch/NDA FARs (7356.021A/B)

Elise Murphy

(301) 796-7565

elise.murphy@fda.hhs.gov

Pre-approval Inspections (NDA/ANDA/BLA) (7346.832)

Concepcion Cruz

(301) 796-3254

concepcion.cruz@fda.hhs.gov

Tara Gooen

(301) 796-3257

tara.gooen@fda.hhs.gov