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About FDA
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Division of Manufacturing and Product Quality (HFD-320): CGMP Subject Contacts as of September 22, 2009
- Subject Contacts
- CDER Compliance Program Contacts:
Subject Contacts
| Subject | Contact Name | Contact Phone | Contact Email |
|---|---|---|---|
| Active Pharmaceutical Ingredients (API) | Anthony Charity | (301) 796-3208 | anthony.charity@fda.hhs.gov |
| Zi Qiang Gu | (301) 796-3195 | ziqiang.gu@fda.hhs.gov | |
| Larry Ouderkirk | (301) 796-1585 | Larry.Ouderkirk@fda.hhs.gov | |
| Air Handling (HVAC) | Edwin Melendez | (301) 796-3284 | edwin.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 |
| Barry Rothman | (301) 796-3281 | Barry.Rothman@fda.hhs.gov | |
| Aseptic Processing | Anastasia Lolas | (301) 796-1566 | Anastasia.Lolas@fda.hhs.gov |
| Donald Obenhuber | (301) 796-3214 | Donald.Obenhuber@fda.hhs.gov | |
| David Jaworski | (301) 796-3192 | David.Jaworski@fda.hhs.gov | |
| Diane Raccasi | (301) 796-3927 | Diane.Raccasi@fda.hhs.gov | |
| Douglas Campbell | (301) 796-3201 | Douglas.Campbell@fda.hhs.gov | |
| Kristy Zielny | (732) 940-8946 x34 | Kristy.Zielny@fda.hhs.gov | |
| Edwin Melendez | 301-796-3284 | Edwin.Melendez@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 | |
| Colleen Hoyt | (301) 796-3251 | colleen.hoyt@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 | Steve Wolfgang | (301) 796-3264 | Steven.Wolfgang@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 |
| Donald Obenhuber | (301) 796-3214 | Donald.Obenhuber@fda.hhs.gov | |
| Steve Wolfgang | (301) 796-3264 | Steven.Wolfgang@fda.hhs.gov | |
| Colleen Thomas | (301) 796-4853 | Colleen.Thomas@fda.hhs.gov | |
| GMP Case Development | Teddi Lopez | (301) 796-3255 | teddi.lopez@fda.hhs.gov |
| Carmelo Rosa | (301) 796-3667 | Carmelo.Rosa@fda.hhs.gov | |
| Cleaning Validation | Edwin Melendez | (301) 796-3284 | Edwin.Melendez@fda.hhs.gov |
| Bo Chi (Biotech) | (301) 796-3190 | Bo.Chi@fda.hhs.gov | |
| Clinical Significance | Karen Hirshfield | (301) 796-1748 | Karen.Hirshfield@fda.hhs.gov |
| Clinical Supplies/IND | Anthony Charity | (301) 796-3208 | Anthony.Charity@fda.hhs.gov |
| Cold-Chain Management | Rosa Motta | (301) 796-3282 | rosa.motta@fda.hhs.gov |
| Barry Rothman | (301) 796-3281 | barry.rothman@fda.hhs.gov | |
| Computer Validation | Brian Belz | (301) 796-4279 | Brian.Belz@fda.hhs.gov |
| Steve Hertz | (301) 796-3203 | Steven.Hertz@fda.hhs.gov | |
| George Smith | (301) 796-3205 | George.Smith@fda.hhs.gov | |
| Contract Manufacturing | Rosa Motta | (301) 796-3282 | rosa.motta@fda.hhs.gov |
| Hidee Molina | (301) 796-3671 | hidee.molina@fda.hhs.gov | |
| Cross Contamination (Penicillin & other potent compounds) | Edwin Melendez | (301) 796-3284 | edwin.melendez@fda.hhs.gov |
| Zi Qiang Gu | (301) 796-3195 | ziqiang.gu@fda.hhs.gov | |
| Douglas Campbell | (301) 796-3201 | douglas.campbell@fda.hhs.gov | |
| Design of Experiment (DOE) | Frank Perrella | (301) 796-3265 | Frank.Perrella@fda.hhs.gov |
| Steve Wolfgang | (301) 796-3264 | Steven.Wolfgang@fda.hhs.gov | |
| Vibhakar Shah | (301) 796-1750 | Vibhakar.Shah@fda.hhs.gov | |
| Drug/Device Products (e.g., Metered-Dose Inhalers, Drug Coated Stents) | Grace McNally | (301) 796-3286 | grace.mcnally@fda.hhs.gov |
| Brian Hasselbalch | (301) 796-3279 | brian.hasselbalch@fda.hhs.gov | |
| Steve Hertz | (301) 796-3203 | Steven.Hertz@fda.hhs.gov | |
| Vibhakar Shah | (301) 796-1750 | Vibhakar.Shah@fda.hhs.gov | |
| Establishment Evaluation Systems & Requests (EES) | Shirnette Ferguson | (301) 796-3247 | shirnette.ferguson@fda.hhs.gov |
| Marisa Stock | (301) 796-4753 | Marisa.Stock@fda.hhs.gov | |
| Electronic Records / Signatures | Brian Belz | (301) 796-4279 | Brian.Belz@fda.hhs.gov |
| Steve Hertz | (301) 796-3203 | Steven.Hertz@fda.hhs.gov | |
| George Smith | (301) 796-3205 | George.Smith@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 | Steven Wolfgang | (301) 796-3264 | steven.wolfgang@fda.hhs.gov |
| Barry Rothman | (301) 796-3281 | Barry.Rothman@fda.hhs.gov | |
| Zi Qiang Gu | (301) 796-3195 | ZiQiang.Gu@fda.hhs.gov | |
| Larry Ouderkirk | (301) 796-1585 | Larry.Ouderkirk@fda.hhs.gov | |
| Vibhakar Shah | (301) 796-1750 | vibhakar.shah@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 | |
| Barry Rothman | (301) 796-3281 | barry.rothman@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 | |
| Kristy Zielny | (732) 940-8946 x34 | kristy.zielny@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 Johnson | (301) 796-3334 | elizabeth.johnson@fda.hhs.gov | |
| Anthony Charity | (301) 796-3667 | anthony.charity@fda.hhs.gov | |
| Kristy Zielny | (732) 940-8946 x34 | kristy.zielny@fda.hhs.gov | |
| Marisa Stock | (301) 796-4753 | marisa.stock@fda.hhs.gov | |
| Impurities | Larry Ouderkirk | (301) 796-1585 | larry.ouderkirk@fda.hhs.gov |
| Zi Qiang Gu | (301) 796-3195 | ziqiang.gu@fda.hhs.gov | |
| Anthony Charity | (301) 796-3208 | anthony.charity@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 |
| Giuseppe Randazzo | (301) 796-3277 | Giuseppe.Randazzo@fda.hhs.gov | |
| Anthony Charity | (301) 796-3208 | anthony.charity@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 |
| David Jaworski | (301) 796-3192 | David.Jaworski@fda.hhs.gov | |
| Laboratory (Chemistry) | Paul Haynie | (301) 796-3261 | paul.haynie@fda.hhs.gov |
| Rosa Motta | (301) 796-3282 | rosa.motta@fda.hhs.gov | |
| Tom Savage | (301) 796-3193 | Thomas.Savage@fda.hhs.gov | |
| Zi Qiang Gu | (301) 796-3195 | ziqiang.gu@fda.hhs.gov | |
| Brian Belz | (301) 796-4279 | Brian.Belz@fda.hhs.gov | |
| Rafael Arroyo | (301) 796-4839 | Rafael.Arroyo@fda.hhs.gov | |
| Concepcion Cruz | (301) 796-3254 | Concepcion.Cruz@fda.hhs.gov | |
| Ray Brown | (301) 796-3256 | raymond.brown@fda.hhs.gov | |
| Vibhakar Shah | (301) 796-1750 | Vibhakar.Shah@fda.hhs.gov | |
| Mary Farbman (biotech) | (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 | Teddi Lopez | (301) 796-3255 | Teddi.Lopez@fda.hhs.gov |
| Barry Rothman | (301) 796-3281 | Barry.Rothman@fda.hhs.gov | |
| Rosa Motta | (301) 796-3282 | Rosa.Motta@fda.hhs.gov | |
| Lyophilization | Edwin Melendez | (301) 796-3284 | edwin.melendez@fda.hhs.gov |
| Colleen Thomas | (301) 796-4853 | Colleen.Thomas@fda.hhs.gov | |
| Medical Gases | Paul Haynie | (301) 796-3261 | paul.haynie@fda.hhs.gov |
| Steven Thurber | (301) 796-3258 | steven.thurber@fda.hhs.gov | |
| Larry Ouderkirk | (301) 796-1585 | Larry.Ouderkirk@fda.hhs.gov | |
| Nanotechnology | Steve Wolfgang | (301) 796-3264 | steven.wolfgang@fda.hhs.gov |
| Vibhakar Shah | (301) 796-1750 | Vibhakar.Shah@fda.hhs.gov | |
| Out-of-Specification | Kristy Zielny | (732) 940-8946 x34 | Kristy.Zielny@fda.hhs.gov |
| Paul Haynie | (301) 796-3261 | paul.haynie@fda.hhs.gov | |
| Grace McNally | (301) 796-3286 | grace.mcnally@fda.hhs.gov | |
| Luis Dasta | (301) 796-3196 | Luis.Dasta@fda.hhs.gov | |
| Brian Belz | (301) 796-4279 | Brian.Belz@fda.hhs.gov | |
| Rafael Arroyo | (301) 796-4839 | Rafael.Arroyo@fda.hhs.gov | |
| Packaging, Repackaging, & Labeling Control | Barry Rothman | (301) 796-3281 | barry.rothman@fda.hhs.gov |
| Hidee Molina | (301) 796-3671 | hidee.molina@fda.hhs.gov | |
| Parametric Release | Tara Gooen | (301) 796-3257 | Tara.Gooen@fda.hhs.gov |
| David Jaworski | (301) 796-3192 | David.Jaworski@fda.hhs.gov | |
| Anastasia Lolas | (301) 796-1566 | Anastasia.Lolas@fda.hhs.gov | |
| Donald Obenhuber | (301) 796-3214 | Donald.Obenhuber@fda.hhs.gov | |
| Pharmacies, CGMP | Karen Hirshfield | (301) 796-1748 | karen.hirshfield@fda.hhs.gov |
| Steve Thurber | (301) 796-3258 | Steven.thurber@fda.hhs.gov | |
| Positron Emission Tomography (PET) | Brenda Uratani | (301) 796-3252 | brenda.uratani@fda.hhs.gov |
| David Jaworski | (301) 796-3192 | David.Jaworski@fda.hhs.gov | |
| Tamara Felton | (301) 796-4162 | Tamara.Felton@fda.hhs.gov | |
| Frank Perrella | (301) 796-3265 | Frank.Perrella@fda.hhs.gov | |
| Metitia Gramby | (301) 796-4238 | Metitia.Gramby@fda.hhs.gov | |
| Anastasia Lolas | (301) 796-1566 | Anastasia.Lolas@fda.hhs.gov | |
| Pre-Approval Inspections (BLA) |
Patricia Hughes | (301) 796-3189 | Patricia.Hughes@fda.hhs.gov |
| Colleen Hoyt | (301) 796-3251 | colleen.hoyt@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 | |
| Shirnette Ferguson | (301) 796-3247 | shirnette.ferguson@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 | |
| David Jaworski | (301) 796-3192 | David.Jaworski@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 |
| Luis Dasta | (301) 796-3196 | Luis.Dasta@fda.hhs.gov | |
| Brian Belz | (301) 796-4279 | Brian.Belz@fda.hhs.gov | |
| Rafael Arroyo | (301) 796-4839 | Rafael.Arroyo@fda.hhs.gov | |
| Recalls, Shortages & Emergencies | Lavonia Huff (Recalls) | (301) 796-3202 | lavonia.huff@fda.hhs.gov |
| Israel Santiago (Recalls, & Emergencies) | (301) 796-3285 | israel.santiago@fda.hhs.gov | |
| Karen Hirshfield (Recalls, Shortages, & Emergencies) | (301) 796-1748 | karen.hirshfield@fda.hhs.gov | |
| Reprocessing, Reworking & Salvaging | Anthony Charity | (301) 796-3208 | anthony.charity@fda.hhs.gov |
| Barry Rothman | (301) 796-3281 | barry.rothman@fda.hhs.gov | |
| RFID | Steven Wolfgang | (301) 796-3264 | steven.wolfgang@fda.hhs.gov |
| David Jaworski | (301) 796-3192 | David.Jaworski@fda.hhs.gov | |
| Risk Assessment Methods | Brian Hasselbalch | (301) 796-3279 | brian.hasselbalch@fda.hhs.gov |
| Steven Wolfgang | (301) 796-3264 | steven.wolfgang@fda.hhs.gov | |
| Scale-up | Steve Wolfgang | (301) 796-3264 | steven.wolfgang@fda.hhs.gov |
| Shawn Gould | (301) 796-3759 | Shawn.Gould@fda.hhs.gov | |
| Tara Gooen | (301) 796-3257 | tara.gooen@fda.hhs.gov | |
| Zi Qiang Gu | (301) 796-3195 | ziqiang.gu@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 | |
| David Jaworski | (301) 796-3192 | David.Jaworski@fda.hhs.gov | |
| Metitia Gramby | (301) 796-4238 | Metitia.Gramby@fda.hhs.gov | |
| Zi Qiang Gu | (301) 796-3195 | ZIqiang.gu@fda.hhs.gov | |
| Stability/Expiration Dates | Barry Rothman | (301) 796-3281 | barry.rothman@fda.hhs.gov |
| Rosa Motta | (301) 796-3282 | rosa.motta@fda.hhs.gov | |
| Zi Qiang Gu | (301) 796-3195 | ziqiang.gu@fda.hhs.gov | |
| Rafael Arroyo | (301) 796-4839 | Rafael.Arroyo@fda.hhs.gov | |
| Vibhakar Shah | (301) 796-1750 | Vibhakar.Shah@fda.hhs.gov | |
| Sterilization/Terminal | Donald Obenhuber | (301) 796-3214 | Donald.Obenhuber@fda.hhs.gov |
| Anastasia Lolas | (301) 796-1566 | Anastasia.Lolas@fda.hhs.gov | |
| Edwin Melendez | (301) 796-3284 | edwin.melendez@fda.hhs.gov | |
| Tara Gooen | (301) 796-3257 | tara.gooen@fda.hhs.gov | |
| David Jaworski | (301) 796-3192 | David.Jaworski@fda.hhs.gov | |
| Supply Chain | Steven Wolfgang | (301) 796-3264 | steven.wolfgang@fda.hhs.gov |
| Barry Rothman | (301) 796-3281 | barry.rothman@fda.hhs.gov | |
| Edwin Rivera | (301) 796-3274 | Edwin.RiveraMartinez@fda.hhs.gov | |
| Tamper-Evident Packaging | Diane Raccasi | (301) 796-3927 | Diane.Raccasi@fda.hhs.gov |
| Topical Drugs | Barry Rothman | (301) 796-3281 | barry.rothman@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 | Brian Hasselbalch | (301) 796-3279 | brian.hasselbalch@fda.hhs.gov |
| Grace McNally | (301) 796-3286 | grace.mcnally@fda.hhs.gov | |
| Larry Ouderkirk | (301) 796-1585 | Larry.Ouderkirk@fda.hhs.gov | |
| 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 |
CDER Compliance Program Contacts
| Subject | Contact Name | Contact Phone | Contact Email |
|---|---|---|---|
| General (7356.002) | Brian Hasselbalch | (301) 796-3279 | brian.hasselbalch@fda.hhs.gov |
| Sterile Processes (7356.002A) | Edwin Melendez | (301) 796-3284 | edwin.melendez@fda.hhs.gov |
| Diane Raccasi | (301) 796-3927 | diane.raccasi@fda.hhs.gov | |
| Repackaging (7356.002B) | Barry Rothman | (301) 796-3281 | barry.rothman@fda.hhs.gov |
| Radiopharmaceuticals (7356.002C) | |||
| Medical Gases (7356.002E) | Paul Haynie | (301) 796-3261 | paul.haynie@fda.hhs.gov |
| Steven Thurber | (301) 796-3258 | steven.thurber@fda.hhs.gov | |
| Active Pharmaceutical Ingredients (7356.002F) | Anthony Charity | (301) 796-3208 | anthony.charity@fda.hhs.gov |
| Licensed Therapeutic Biologicals (7356.002M) | Colleen Hoyt | (301) 796-3251 | colleen.hoyt@fda.hhs.gov |
NDA/ANDA Pre-Approval Inspections
| Subject | Contact Name | Contact Phone | Contact Email |
|---|---|---|---|
| Pre-approval Inspections (7346.832) | Concepcion Cruz | (301) 796-3254 | concepcion.cruz@fda.hhs.gov |
| Tara Gooen | (301) 796-3257 | tara.gooen@fda.hhs.gov | |
| Shirnette Ferguson | (301) 796-3247 | shirnette.ferguson@fda.hhs.gov | |
| Colleen Hoyt | (301) 796-3251 | colleen.hoyt@fda.hhs.gov |
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