Recently Published FDA Form 483s
MIRA, Inc. [Uxbridge / United States of America]
Inspection End Date: June 12, 2024
FEI: 1218813
Location: UXBRIDGE, MASSACHUSETTS, United States of America
Investigators: Katarzyna Plona
Berkshire Sterile Manufacturing, Inc. [Lee / United States of America]
Inspection End Date: June 12, 2024
FEI: 3012144557
Location: LEE, MASSACHUSETTS, United States of America
Investigators: Latorie S Jones, Brentley S Collins
Medtronic Navigation, Inc.-Boxborough [Boxborough / United States of America]
Inspection End Date: June 11, 2024
FEI: 3004785967
Location: BOXBOROUGH, MASSACHUSETTS, United States of America
Investigators: Nabil Nakhoul
Stratus BioSystems, LLC [Grapevine / United States of America]
Inspection End Date: June 11, 2024
FEI: 3014171113
Location: GRAPEVINE, TEXAS, United States of America
Investigators: Richard T Riggie, Ramon Lgonzalez Prieto, Ramon Lgonzales Prieto
Peter Michael, M.D. [Hialeah / United States of America]
Inspection End Date: June 11, 2024
FEI: 3030605411
Location: HIALEAH, FLORIDA, United States of America
Investigators: LCDR Angelica M Chica
VFX Laboratories LLC [Grapevine / United States of America]
Inspection End Date: June 11, 2024
FEI: 3030377014
Location: GRAPEVINE, TEXAS, United States of America
Investigators: Richard T Riggie, Ramon Lgonzalez Prieto
Medical Chemical Corporation [Torrance / United States of America]
Inspection End Date: June 10, 2024
FEI: 2013736
Location: TORRANCE, CALIFORNIA, United States of America
Investigators: Juanita Banuelos, Nga T Ho
Dr Reddy's Laboratories Limited [Ranastalam / India]
Inspection End Date: June 7, 2024
FEI: 3002949085
Location: RANASTALAM, ANDHRA PRADESH, India
Investigators: Joseph A Piechocki, Tamil Arasu, PhD
California Cryobank LLC d.b.a. Cooper Surgical [New York / United States of America]
Inspection End Date: June 7, 2024
FEI: 3005202248
Location: NEW YORK, NEW YORK, United States of America
Investigators: Irina Gaberman
Olga M. Lapeyra, M.D. [Miami Lakes / United States of America]
Inspection End Date: June 7, 2024
FEI: 3019970587
Location: MIAMI LAKES, FLORIDA, United States of America
Investigators: Chantae D Mitchell
RCRC Independent Review Board (IRB) dba Salus IRB [Austin / United States of America]
Inspection End Date: June 7, 2024
FEI: 1643401
Location: AUSTIN, TEXAS, United States of America
Investigators: Iris C Macinnes, Lan T Tran
MPP Group, LLC [Mequon / United States of America]
Inspection End Date: June 7, 2024
FEI: 3012680240
Location: MEQUON, WISCONSIN, United States of America
Investigators: Lori B Wikstrom
STYRAX LIFE SCIENCES PRIVATE LIMITED [Rambili / India]
Inspection End Date: June 7, 2024
FEI: 3018393466
Location: RAMBILI, ANDHRA PRADESH, India
Investigators: Dogbeda F Mackenzie
Chemblend of America LLC [Bensenville / United States of America]
Inspection End Date: June 7, 2024
FEI: 3002992961
Location: BENSENVILLE, ILLINOIS, United States of America
Investigators: Matthew B Casale, Tyler M Peterson
Acera Surgical Inc [Woodstock / United States of America]
Inspection End Date: June 7, 2024
FEI: 3012429393
Location: WOODSTOCK, GEORGIA, United States of America
Investigators: Nikki S Bryant
POINT Biopharma USA Inc. [Indianapolis / United States of America]
Inspection End Date: June 7, 2024
FEI: 3017226344
Location: INDIANAPOLIS, INDIANA, United States of America
Investigators: Muna Algharibeh, Matthew M Schuckmann
Wockhardt USA LLC [Parsippany / United States of America]
Inspection End Date: June 6, 2024
FEI: 3003060524
Location: PARSIPPANY, NEW JERSEY, United States of America
Investigators: Mayar M Mussa
ZYTO Technologies, Inc. [Pleasant Grove / United States of America]
Inspection End Date: June 6, 2024
FEI: 3008493238
Location: PLEASANT GROVE, UTAH, United States of America
Investigators: Eric C Fox
Essations, Inc [South Chicago Heights / United States of America]
Inspection End Date: June 6, 2024
FEI: 3015310281
Location: SOUTH CHICAGO HEIGHTS, ILLINOIS, United States of America
Investigators: Matthew B Casale, Tyler M Peterson
Empyrean Medical Systems Inc [Boca Raton / United States of America]
Inspection End Date: June 5, 2024
FEI: 3023344262
Location: BOCA RATON, FLORIDA, United States of America
Investigators: Gisselle I Sensebe, David M Wilkinson
Ungerer and Company [Bethlehem / United States of America]
Inspection End Date: June 5, 2024
FEI: 1000121391
Location: BETHLEHEM, PENNSYLVANIA, United States of America
Investigators: Anastasia M Shields, Rahi D Patel, Rahi Patel
Synchronis Medical Llc [Romulus / United States of America]
Inspection End Date: June 4, 2024
FEI: 3014527916
Location: ROMULUS, MICHIGAN, United States of America
Investigators: Felicia E Armbrustmacher
Phoenix Thera-Lase Systems LLC [Dallas / United States of America]
Inspection End Date: June 3, 2024
FEI: 3013491757
Location: DALLAS, TEXAS, United States of America
Investigators: Matthew M Vernon
Matthew A. Powell, M.D. [Saint Louis / United States of America]
Inspection End Date: June 3, 2024
FEI: 3030691560
Location: SAINT LOUIS, MISSOURI, United States of America
Investigators: Logan M Jones
Zoe Medical Incorporated [Topsfield / United States of America]
Inspection End Date: May 31, 2024
FEI: 3003294644
Location: TOPSFIELD, MASSACHUSETTS, United States of America
Investigators: Sunita Pandey
AFP Manufacturing [Edgewater / United States of America]
Inspection End Date: May 31, 2024
FEI: 3013400823
Location: EDGEWATER, FLORIDA, United States of America
Investigators: Ronald Ifraimov
Furst-McNess Company [Lake City / United States of America]
Inspection End Date: May 31, 2024
FEI: 3002787852
Location: LAKE CITY, FLORIDA, United States of America
Investigators: Alec D Fabus
Mark V. DiBuono, MD [Staten Island / United States of America]
Inspection End Date: May 31, 2024
FEI: 3007159391
Location: STATEN ISLAND, NEW YORK, United States of America
Investigators: Roberto A Dookhan
RK PHARMA INC [Pearl River / United States of America]
Inspection End Date: May 31, 2024
FEI: 3014926340
Location: PEARL RIVER, NEW YORK, United States of America
Investigators: Ruben C Quintana, Brandy N Lepage
Irvington Seafood, Inc. dba ISF, Inc. [Irvington / United States of America]
Inspection End Date: May 31, 2024
FEI: 1000113098
Location: IRVINGTON, ALABAMA, United States of America
Investigators: Samuel L Collins, Shannon Atlas
Knickerbocker 365 Inc. [Madison Heights / United States of America]
Inspection End Date: May 31, 2024
FEI: 3003613292
Location: MADISON HEIGHTS, MICHIGAN, United States of America
Investigators: Nicholas E Boyd, John N Woodall
Naturavit Inc [Miami / United States of America]
Inspection End Date: May 31, 2024
FEI: 3003779775
Location: MIAMI, FLORIDA, United States of America
Investigators: Benita C Okeke
Robbins Instruments, LLC [Houston / United States of America]
Inspection End Date: May 31, 2024
FEI: 2221941
Location: HOUSTON, TEXAS, United States of America
Investigators: Jocelyn C Turner
American Distribution and Manufacturing Co, LLC [Cottage Grove / United States of America]
Inspection End Date: May 30, 2024
FEI: 3003974891
Location: COTTAGE GROVE, MINNESOTA, United States of America
Investigators: Karla J Youngberg
B & J Medical LLC. [Kendallville / United States of America]
Inspection End Date: May 30, 2024
FEI: 3009973699
Location: KENDALLVILLE, INDIANA, United States of America
Investigators: Suyang Qin
Equibal, Inc. [Unionville / United States of America]
Inspection End Date: May 30, 2024
FEI: 3003440513
Location: UNIONVILLE, NEW YORK, United States of America
Investigators: Ifechimere I Okafor, Paige R Mccoy, Puspa Suresh Jayasekara
Ossium Health Inc [Indianapolis / United States of America]
Inspection End Date: May 30, 2024
FEI: 3018425658
Location: INDIANAPOLIS, INDIANA, United States of America
Investigators: Lesley Maep Lutao
Joshua D. Woolley, M.D. [San Francisco / United States of America]
Inspection End Date: May 30, 2024
FEI: 3030956515
Location: SAN FRANCISCO, CALIFORNIA, United States of America
Investigators: Scott N Lim
Stony Brook Community Medical PC - Island Fertility [Commack / United States of America]
Inspection End Date: May 28, 2024
FEI: 3015335677
Location: COMMACK, NEW YORK, United States of America
Investigators: Irina Gaberman
MSD Ireland (Carlow) [Carlow / Ireland]
Inspection End Date: May 28, 2024
FEI: 3008694906
Location: CARLOW, CARLOW, Ireland
Investigators: Michael Shanks, MS, Dr. Ralph M Bernstein, PhD, Jennifer E Veenhof
Lyophilization Services Of New England, Inc. (LSNE) [Bedford / United States of America]
Inspection End Date: May 24, 2024
FEI: 3008546445
Location: BEDFORD, NEW HAMPSHIRE, United States of America
Investigators: Karishma G Gopaul, Sean R Marcsisin
Patheon Manufacturing Services LLC [Greenville / United States of America]
Inspection End Date: May 24, 2024
FEI: 1018495
Location: GREENVILLE, NORTH CAROLINA, United States of America
Investigators: Saundrea A Munroe, Zhong Li, PhD, Melanie M Walker
Mylan Laboratories Limited [Sinnar / India]
Inspection End Date: May 24, 2024
FEI: 3005587313
Location: SINNAR, MAHARASHTRA, India
Investigators: Arsen Karapetyan, Wayne D Mcgrath
Cafe Valley Bakery, LLC [Marion / United States of America]
Inspection End Date: May 24, 2024
FEI: 3011281803
Location: MARION, INDIANA, United States of America
Investigators: Antonio M Hampton, Brian J Davis, Tessy O Martins, Misty D Harvey
Spectrum Medical Inc [Fort Mill / United States of America]
Inspection End Date: May 24, 2024
FEI: 3006126428
Location: FORT MILL, SOUTH CAROLINA, United States of America
Investigators: Dawn M Braswell
Oxid Corporation [Novi / United States of America]
Inspection End Date: May 23, 2024
FEI: 3017929928
Location: NOVI, MICHIGAN, United States of America
Investigators: David J Gasparovich
Pace Analytical Services, LLC [Williamsport / United States of America]
Inspection End Date: May 23, 2024
FEI: 3012268760
Location: WILLIAMSPORT, PENNSYLVANIA, United States of America
Investigators: Evan Tong, Karen A Briggs
Element Materials Technology Midland Inc. [Midland / United States of America]
Inspection End Date: May 23, 2024
FEI: 3004518270
Location: MIDLAND, MICHIGAN, United States of America
Investigators: Ramia Brzenjy, Melissa M Steiger, Nicholas J Presto
Akili Interactive Labs, Inc. [Boston / United States of America]
Inspection End Date: May 23, 2024
FEI: 3013341423
Location: BOSTON, MASSACHUSETTS, United States of America
Investigators: James P Finn
QOSTRONICS [San Jose / United States of America]
Inspection End Date: May 23, 2024
FEI: 3008717564
Location: SAN JOSE, CALIFORNIA, United States of America
Investigators: Brittany D Mccracken
Mehdi Hamadani, M.D [Milwaukee / United States of America]
Inspection End Date: May 23, 2024
FEI: 3030241242
Location: MILWAUKEE, WISCONSIN, United States of America
Investigators: Denise L Burosh
QBTech Inc. [Houston / United States of America]
Inspection End Date: May 23, 2024
FEI: 3023138809
Location: HOUSTON, TEXAS, United States of America
Investigators: Ellen J Tave
PATHWAY MEDTECH, LLC [Santee / United States of America]
Inspection End Date: May 22, 2024
FEI: 3012833053
Location: SANTEE, CALIFORNIA, United States of America
Investigators: Juanj N Wu
Calmare Therapeutics, Inc. [Shelton / United States of America]
Inspection End Date: May 22, 2024
FEI: 3006435903
Location: SHELTON, CONNECTICUT, United States of America
Investigators: Katarzyna Plona
Suntech Medical, Inc. [Morrisville / United States of America]
Inspection End Date: May 22, 2024
FEI: 1036863
Location: MORRISVILLE, NORTH CAROLINA, United States of America
Investigators: Inga M Warr
Sterilmed, Inc. [Minneapolis / United States of America]
Inspection End Date: May 22, 2024
FEI: 3011276773
Location: MINNEAPOLIS, MINNESOTA, United States of America
Investigators: Benjamin W Anderson
Ziptek LLC [Sarasota / United States of America]
Inspection End Date: May 22, 2024
FEI: 3013722959
Location: SARASOTA, FLORIDA, United States of America
Investigators: Ulysses D Singleton
Tom's of Maine, Inc. [Sanford / United States of America]
Inspection End Date: May 22, 2024
FEI: 1218077
Location: SANFORD, MAINE, United States of America
Investigators: Lori M Newman
American CryoStem Corporation [Monmouth Junction / United States of America]
Inspection End Date: May 22, 2024
FEI: 3008307548
Location: MONMOUTH JUNCTION, NEW JERSEY, United States of America
Investigators: Amy A Johnson, Michele Gottshall
Thorn BioScience [Louisville / United States of America]
Inspection End Date: May 22, 2024
FEI: 3004471600
Location: LOUISVILLE, KENTUCKY, United States of America
Investigators: Rafeeq A Habeeb
Medstar Cardiovascular Research Network [Washington / United States of America]
Inspection End Date: May 22, 2024
FEI: 3030013480
Location: WASHINGTON, DISTRICT OF COLUMBIA, United States of America
Investigators: David L Chon
Warner Graham LLLP [Cockeysville / United States of America]
Inspection End Date: May 21, 2024
FEI: 1110202
Location: COCKEYSVILLE, MARYLAND, United States of America
Investigators: David A Oluwo
CooperSurgical, Inc. [Trumbull / United States of America]
Inspection End Date: May 21, 2024
FEI: 1216677
Location: TRUMBULL, CONNECTICUT, United States of America
Investigators: Tomika L Crafter, Pamela N Agaba, Tanya R Syffrard
MANAMED INC. [Denton / United States of America]
Inspection End Date: May 21, 2024
FEI: 3011767724
Location: DENTON, TEXAS, United States of America
Investigators: Jacey Roy
Blooming Import Inc. [Brooklyn / United States of America]
Inspection End Date: May 17, 2024
FEI: 2460055
Location: BROOKLYN, NEW YORK, United States of America
Investigators: Edwin A Evangelista
Visionary Optics, LLC [Front Royal / United States of America]
Inspection End Date: May 17, 2024
FEI: 1000123221
Location: FRONT ROYAL, VIRGINIA, United States of America
Investigators: Tiki J Dixon
Analytical Food Laboratories [Grand Prairie / United States of America]
Inspection End Date: May 17, 2024
FEI: 3005057567
Location: GRAND PRAIRIE, TEXAS, United States of America
Investigators: Oluwasefunm Agbanigo, Samantha E Cleek, Margaret M Annes
Tenda Horse Products LLC [Sandusky / United States of America]
Inspection End Date: May 17, 2024
FEI: 3005916117
Location: SANDUSKY, OHIO, United States of America
Investigators: Paranthaman Senthamaraikannan
Lewis Sausage Company, Inc. [Burgaw / United States of America]
Inspection End Date: May 17, 2024
FEI: 3004000736
Location: BURGAW, NORTH CAROLINA, United States of America
Investigators: Sandra R Saunders, Anthony S Puckett, Jhakeim D Seaberry, Joseph R Haynes
Dr. G. H. Tichenor's Antiseptic Company [New Orleans / United States of America]
Inspection End Date: May 17, 2024
FEI: 2311409
Location: NEW ORLEANS, LOUISIANA, United States of America
Investigators: Brittny C Cargo
Calyx Chemicals and Pharmaceuticals Limited [Boisar Rural / India]
Inspection End Date: May 17, 2024
FEI: 3003721861
Location: BOISAR RURAL, MAHARASHTRA, India
Investigators: Guerlain Ulysse, Yvins Dezan
Sun Pharmaceutical Industries Limited [Vagra / India]
Inspection End Date: May 17, 2024
FEI: 3010027135
Location: VAGRA, GUJARAT, India
Investigators: Haitao Li, Santos E Camara
Texas Biomedical Research Institute [San Antonio / United States of America]
Inspection End Date: May 17, 2024
FEI: 1626181
Location: SAN ANTONIO, TEXAS, United States of America
Investigators: Andrew R Wasko, Joanne M Schlossin
Integrated Laboratory Systems LLC, An Inotiv Company [Morrisville / United States of America]
Inspection End Date: May 17, 2024
FEI: 3003722197
Location: MORRISVILLE, NORTH CAROLINA, United States of America
Investigators: Anthony J Grace, Erin M Mcdowell
Southwest Technologies Inc [Kansas City / United States of America]
Inspection End Date: May 16, 2024
FEI: 1929833
Location: KANSAS CITY, MISSOURI, United States of America
Investigators: Hammam A Abdallah, Eric C Fox
Diamond Chemical Co Inc [East Rutherford / United States of America]
Inspection End Date: May 16, 2024
FEI: 3003994440
Location: EAST RUTHERFORD, NEW JERSEY, United States of America
Investigators: Jenny Sung, Yaharn Su, Victoria Spivak
Kenneth B. Strenge, MD [Paducah / United States of America]
Inspection End Date: May 16, 2024
FEI: 3015908064
Location: PADUCAH, KENTUCKY, United States of America
Investigators: Kellie R Riggs
TF Health Corp. [Tempe / United States of America]
Inspection End Date: May 16, 2024
FEI: 3012066447
Location: TEMPE, ARIZONA, United States of America
Investigators: Stephen R Souza, Scott D Stevens
Source One International [Bridgewater / United States of America]
Inspection End Date: May 15, 2024
FEI: 3010940776
Location: BRIDGEWATER, NEW JERSEY, United States of America
Investigators: Willy A Orantes, Coleburn E Vielehr
University of California Irvine Medical Center Campus Donor Center [Irvine / United States of America]
Inspection End Date: May 15, 2024
FEI: 3006073570
Location: IRVINE, CALIFORNIA, United States of America
Investigators: Maurine Fadlalla, Emily B Camire
Aurobindo Pharma USA Inc [East Windsor / United States of America]
Inspection End Date: May 15, 2024
FEI: 3008460374
Location: EAST WINDSOR, NEW JERSEY, United States of America
Investigators: Samir C Gala
AAA Pharmaceutical, Inc. [Paulsboro / United States of America]
Inspection End Date: May 15, 2024
FEI: 2246707
Location: PAULSBORO, NEW JERSEY, United States of America
Investigators: Yoriann M Cabrera Bartolomei, Amy N Chen
Jacoby Feed & Seed [Melvin / United States of America]
Inspection End Date: May 15, 2024
FEI: 3003767628
Location: MELVIN, TEXAS, United States of America
Investigators: Jody Goudwin, Scott Headley
Maps Public Benefit Corporation [Santa Cruz / United States of America]
Inspection End Date: May 15, 2024
FEI: 3025253687
Location: SANTA CRUZ, CALIFORNIA, United States of America
Investigators: Kristin M Abaonza
Advanced Maternity Innovations [Houston / United States of America]
Inspection End Date: May 15, 2024
FEI: 3010608577
Location: HOUSTON, TEXAS, United States of America
Investigators: Amber Smith
Evoqua Water Technologies LLC [Buena Park / United States of America]
Inspection End Date: May 14, 2024
FEI: 3009553888
Location: BUENA PARK, CALIFORNIA, United States of America
Investigators: Juanita Banuelos
Northland Health Products for Pets Inc. [Minneapolis / United States of America]
Inspection End Date: May 13, 2024
FEI: 3015335911
Location: MINNEAPOLIS, MINNESOTA, United States of America
Investigators: Karla J Youngberg
Southern Spectrographic Laboratory, Inc. [Arlington / United States of America]
Inspection End Date: May 11, 2024
FEI: 3012802209
Location: ARLINGTON, TEXAS, United States of America
Investigators: Mabany Lizardi, Margaret M Annes, Dorothy P Kramer
Brookfield Medical/Surgical Supplies, Inc. [Brookfield / United States of America]
Inspection End Date: May 10, 2024
FEI: 3011430551
Location: BROOKFIELD, CONNECTICUT, United States of America
Investigators: Ogechi C Nna, Armen H Youssoufian, Jonathan G Matrisciano
Denver Fertility Care [Englewood / United States of America]
Inspection End Date: May 10, 2024
FEI: 3010133797
Location: ENGLEWOOD, COLORADO, United States of America
Investigators: Garrad R Poole
FUJIFILM Wako Chemicals U.S.A. Corporation [North Chesterfield / United States of America]
Inspection End Date: May 10, 2024
FEI: 1627434
Location: NORTH CHESTERFIELD, VIRGINIA, United States of America
Investigators: Edward A Brunt, Christian D Lynch (CDL), Nisha C Patel
Sanitor Corporation [Stanton / United States of America]
Inspection End Date: May 10, 2024
FEI: 3005871025
Location: STANTON, CALIFORNIA, United States of America
Investigators: Darren S Brown
Clean Solutions LLC [Clifton / United States of America]
Inspection End Date: May 10, 2024
FEI: 3012305678
Location: CLIFTON, NEW JERSEY, United States of America
Investigators: Olumide A Akinyemi, Catherine O Lamptey, Vivin George
Surgical Technology Laboratories, Inc [Lugoff / United States of America]
Inspection End Date: May 10, 2024
FEI: 1825527
Location: LUGOFF, SOUTH CAROLINA, United States of America
Investigators: Gamal A Norton
Medical Murray Inc. [Lake Zurich / United States of America]
Inspection End Date: May 10, 2024
FEI: 3003473227
Location: LAKE ZURICH, ILLINOIS, United States of America
Investigators: Jesse A Vazquez
BioTek America LLC [Nacogdoches / United States of America]
Inspection End Date: May 9, 2024
FEI: 3021500737
Location: NACOGDOCHES, TEXAS, United States of America
Investigators: Michelle Paxon
Viscus Biologics LLC [Cleveland / United States of America]
Inspection End Date: May 9, 2024
FEI: 3013012623
Location: CLEVELAND, OHIO, United States of America
Investigators: Laureen M Geniusz
Northern Food I/E Inc. [Westbury / United States of America]
Inspection End Date: May 8, 2024
FEI: 3005313357
Location: WESTBURY, NEW YORK, United States of America
Investigators: Loretta J Miller
Meritus Medical Laboratory [Hagerstown / United States of America]
Inspection End Date: May 8, 2024
FEI: 1170632
Location: HAGERSTOWN, MARYLAND, United States of America
Investigators: Kenneth L Smalls, Danielle R Rainey, Victoria V Bot
Cipla Ltd. [Daund Sub-District / India]
Inspection End Date: May 8, 2024
FEI: 3002806702
Location: DAUND SUB-DISTRICT, MAHARASHTRA, India
Investigators: Haitao Li, Santos E Camara
I am working in QA department of Pharmaceutical company, I am updating myself about FDA requirements.