| Subject |
Contact Name |
Contact Phone |
Contact Email |
| Active Pharmaceutical Ingredients (API) |
Anthony Charity |
(301) 796-3208 |
anthony.charity@fda.hhs.gov |
| Albinus D’Sa |
(301) 796-3253 |
albinus.dsa@fda.hhs.gov |
| Monica Caphart |
(301) 796-3248 |
monica.caphart@fda.hhs.gov |
| Zi Qiang Gu |
(301) 796-3195 |
ziqiang.gu@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 |
| Aseptic Processing |
Brenda Uratani |
(301) 796-3252 |
brenda.uratani@fda.hhs.gov |
| Douglas Campbell |
(301) 796-3201 |
douglas.campbell@fda.hhs.gov |
| Biotechnology Products & Facility Reviews |
Patricia Hughes |
(301) 796-3189 |
patricia.hughes@fda.hhs.gov |
| Michelle Clark-Stuart |
(301) 796-3197 |
michelle.clark-stuart@fda.hhs.gov |
| Colleen Hoyt |
(301) 796-3251 |
colleen.hoyt@fda.hhs.gov |
| Blend Uniformity |
Mike Gavini |
(301) 796-3204 |
mural.gavini@fda.hhs.gov |
| Botanicals Manufacturing |
Albinus D’Sa |
(301) 796-3253 |
albinus.dsa@fda.hhs.gov |
| Brian Hasselbalch |
(301) 796-3279 |
brian.hasselbalch@fda.hhs.gov |
| Bovine Spongiform Encephalopathy |
Mike Gavini |
(301) 796-3204 |
mural.gavini@fda.hhs.gov |
| Steven Wolfgang |
(301) 796-3264 |
steven.wolfgang@fda.hhs.gov |
| Case Development |
Teddi Lopez |
(301) 796-3255 |
teddi.lopez@fda.hhs.gov |
| Cleaning Validation |
Albinus D'Sa |
(301) 796-3253 |
albinus.dsa@fda.hhs.gov |
| Mike Gavini |
(301) 796-3204 |
mural.gavini@fda.hhs.gov |
| Alicia Mozzachio |
(301) 796-3206 |
alicia.mozzachio@fda.hhs.gov |
| Steven Wolfgang |
(301) 796-3264 |
steven.wolfgang@fda.hhs.gov |
| Clinical Significance |
Alicia Mozzachio |
(301) 796-3206 |
alicia.mozzachio@fda.hhs.gov |
| Karen Hirshfield |
(301) 796-1748 |
karen.hirshfield@fda.hhs.gov |
| Clinical Supplies/IND |
Monica Caphart |
(301) 796-3248 |
monica.caphart@fda.hhs.gov |
| Brenda Uratani |
(301) 796-3252 |
brenda.uratani@fda.hhs.gov |
| 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 |
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) |
Albinus D’Sa |
(301) 796-3253 |
albinus.dsa@fda.hhs.gov |
| Frank Perrella |
(301) 796-3265 |
frank.perrella@fda.hhs.gov |
| Steven Wolfgang |
(301) 796-3264 |
steven.wolfgang@fda.hhs.gov |
| Mike Gavini |
(301) 796-3204 |
mural.gavini@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 |
| Establishment Evaluation Systems & Requests (EES) |
Shirnette Ferguson |
(301) 796-3247 |
shirnette.ferguson@fda.hhs.gov |
| Shawnte Adams |
(301) 796-3193 |
shawnte.adams@fda.hhs.gov |
| Electronic Records / Signatures |
George Smith |
(301) 796-3205 |
george.smith@fda.hhs.gov |
| Endotoxins / Pyrogens |
Brenda Uratani |
(301) 796-3252 |
brenda.uratani@fda.hhs.gov |
| Excipients |
Steven Wolfgang |
(301) 796-3264 |
steven.wolfgang@fda.hhs.gov |
| Monica Caphart |
(301) 796-3248 |
monica.caphart@fda.hhs.gov |
| Albinus D’Sa |
(301) 796-3253 |
albinus.dsa@fda.hhs.gov |
| Barry Rothman |
(301) 796-3281 |
barry.rothman@fda.hhs.gov |
| Export Certificates |
Betty McRoy |
(301) 796-3218 |
betty.mcroy@fda.hhs.gov |
| Marta Gonzalez-Pineiro |
(301) 796-3283 |
marta.gonzalez@fda.hhs.govv |
| Facilities and Equipment (General) |
Tara Gooen |
(301) 796-3257 |
tara.gooen@fda.hhs.gov |
| Douglas Campbell |
(301) 796-3201 |
douglas.campbell@fda.hhs.gov |
| Fermentation / Cell Culture |
Patricia Hughes |
(301) 796-3189 |
patricia.hughes@fda.hhs.gov |
| Brenda Uratani |
(301) 796-3252 |
brenda.uratani@fda.hhs.gov |
| Foreign Inspections |
Anthony Charity |
(301) 796-3208 |
anthony.charity@fda.hhs.gov |
| Carmelo Rosa |
(301) 796-3667 |
carmelo.rosa@fda.hhs.gov |
| Shawnte Adams |
(301) 796-3193 |
shawnte.adams@fda.hhs.gov |
| Impurities |
Anthony Charity |
(301) 796-3208 |
anthony.charity@fda.hhs.gov |
| Zi Qiang Gu |
(301) 796-3195 |
ziqiang.gu@fda.hhs.gov |
| Albinus D’Sa |
(301) 796-3253 |
albinus.dsa@fda.hhs.gov |
| International CGMP Issues and Agreements |
Brian Hasselbalch |
(301) 796-3279 |
brian.hasselbalch@fda.hhs.gov |
| Monica Caphart |
(301) 796-3248 |
monica.caphart@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 |
| Laboratory (Chemistry) |
Monica Caphart |
(301) 796-3248 |
monica.caphart@fda.hhs.gov |
| Paul Haynie |
(301) 796-3261 |
paul.haynie@fda.hhs.gov |
| Rosa Motta |
(301) 796-3282 |
rosa.motta@fda.hhs.gov |
| Albinus D’Sa |
(301) 796-3253 |
albinus.dsa@fda.hhs.gov |
| Ray Brown |
(301) 796-3256 |
raymond.brown@fda.hhs.gov |
| Zi Qiang Gu |
(301) 796-3195 |
ziqiang.gu@fda.hhs.gov |
| Laboratory (Microbiology) |
Brenda Uratani |
(301) 796-3252 |
brenda.uratani@fda.hhs.gov |
| Patricia Hughes |
(301) 796-3189 |
patricia.hughes@fda.hhs.gov |
| Litigation Guidance and Support |
Nick Buhay |
(301) 796-3272 |
nicholas.buhay@fda.hhs.gov |
| Lyophilization |
Edwin Melendez |
(301) 796-3284 |
edwin.melendez@fda.hhs.gov |
| Albinus D’Sa |
(301) 796-3253 |
albinus.dsa@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 |
| Nanotechnology |
Albinus D’Sa |
(301) 796-3253 |
albinus.dsa@fda.hhs.gov |
| Steven Wolfgang |
(301) 796-3264 |
steven.wolfgang@fda.hhs.gov |
| Out-of-Specification |
Paul Haynie |
(301) 796-3261 |
paul.haynie@fda.hhs.gov |
| Grace McNally |
(301) 796-3286 |
grace.mcnally@fda.hhs.gov |
| Packaging, Repackaging, & Labeling Control |
Barry Rothman |
(301) 796-3281 |
barry.rothman@fda.hhs.gov |
| Alicia Mozzachio |
(301) 796-3206 |
alicia.mozzachio@fda.hhs.gov |
| Hidee Molina |
(301) 796-3671 |
hidee.molina@fda.hhs.gov |
| Parametric Release |
Brenda Uratani |
(301) 796-3252 |
brenda.uratani@fda.hhs.gov |
| Pharmacies, CGMP |
Alicia Mozzachio |
(301) 796-3206 |
alicia.mozzachio@fda.hhs.gov |
| Karen Hirshfield |
(301) 796-1748 |
karen.hirshfield@fda.hhs.gov |
| Positron Emission Tomography (PET) |
Brenda Uratani |
(301) 796-3252 |
brenda.uratani@fda.hhs.gov |
Pre-Approval Inspections
(NDA/ANDA) |
Concepcion Cruz |
(301) 796-3254 |
concepcion.cruz@fda.hhs.gov |
| Edwin Rivera |
(301) 796-3274 |
edwin.riveramartinez@fda.hhs.gov |
| Pre-Approval Inspections (BLA) |
Colleen Hoyt |
(301) 796-3251 |
colleen.hoyt@fda.hhs.gov |
| Process Analytical Technology (PAT) |
Albinus D’Sa (Chemistry) |
(301) 796-3253 |
albinus.dsa@fda.hhs.gov |
| Mike Gavini (Chemistry) |
(301) 796-3204 |
mural.gavini@fda.hhs.gov |
| Brenda Uratani (Microbiology) |
(301) 796-3252 |
brenda.uratani@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 |
| QC Responsibilities |
Monica Caphart |
(301) 796-3248 |
monica.caphart@fda.hhs.gov |
| Grace McNally |
(301) 796-3286 |
grace.mcnally@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 |
| Risk Assessment Methods |
Brian Hasselbalch |
(301) 796-3279 |
brian.hasselbalch@fda.hhs.gov |
| Steven Wolfgang |
(301) 796-3264 |
steven.wolfgang@fda.hhs.gov |
| Solid Oral Drugs |
Zi Qiang Gu |
(301) 796-3195 |
ziqiang.gu@fda.hhs.gov |
| Karen Takahashi |
(301) 796-3191 |
Karen.Takahashi@fda.hhs.gov |
| Mike Gavini |
(301) 796-3204 |
mural.gavini@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 |
| Sterilization/Terminal |
Edwin Melendez |
(301) 796-3284 |
edwin.melendez@fda.hhs.gov |
| Tara Gooen |
(301) 796-3257 |
tara.gooen@fda.hhs.gov |
| Patricia Hughes |
(301) 796-3189 |
patricia.hughes@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 |
| Tamper-Evident Packaging |
Raymond Brown |
(301) 796-3256 |
raymond.brown@fda.hhs.gov |
| Topical Drugs |
Albinus D’Sa |
(301) 796-3253 |
albinusdsa@fda.hhs.gov |
| Barry Rothman |
(301) 796-3281 |
barry.rothman@fda.hhs.gov |
| Yanyan (Jenny) Quin |
(301) 796-3207 |
yanyan.qin@fda.hhs.gov |
| Transdermals |
Brian Hasselbalch |
(301) 796-3279 |
brian.hasselbalch@fda.hhs.gov |
| Grace McNally |
(301) 796-3286 |
grace.mcnally@fda.hhs.gov |
| Water Quality |
Brenda Uratani |
(301) 796-3252 |
brenda.uratani@fda.hhs.gov |
| Tara Gooen |
(301) 796-3257 |
tara.gooen@fda.hhs.gov |
