Recently Published FDA Form 483s
Lonza Manufacturing LLC [Vacaville / United States of America]
Inspection End Date: September 29, 2025
FEI: 3032299571
Location: VACAVILLE, CALIFORNIA, United States of America
Investigators: Youkeun Kim, Jeffrey P Raimondi, Crystal Monroy, Nathan E Hellman, Joey V Quitania, Uttaniti Limchumroon (Tom)
Baxter Healthcare Corporation [Cleveland / United States of America]
Inspection End Date: September 29, 2025
FEI: 1019003
Location: CLEVELAND, MISSISSIPPI, United States of America
Investigators: Camerson E Moore
KANEMATSU USA INC. [San Jose / United States of America]
Inspection End Date: September 29, 2025
FEI: 3022995303
Location: SAN JOSE, CALIFORNIA, United States of America
Investigators: Daniel J Munoz, Savannah E Samp
Day-Lee Foods Inc [Seatac / United States of America]
Inspection End Date: September 29, 2025
FEI: 3012939385
Location: SEATAC, WASHINGTON, United States of America
Investigators: Erica R Mahone
Applied Consumer Services, Inc. [Hialeah / United States of America]
Inspection End Date: September 29, 2025
FEI: 3004957221
Location: HIALEAH, FLORIDA, United States of America
Investigators: Frederick F Razzaghi
Lexia LLC [Franklin / United States of America]
Inspection End Date: September 29, 2025
FEI: 3011863647
Location: FRANKLIN, TENNESSEE, United States of America
Investigators: Inga M Warr
Hetero Labs Limited [Nakkapalle / India]
Inspection End Date: September 26, 2025
FEI: 3009093782
Location: NAKKAPALLE, ANDHRA PRADESH, India
Investigators: Lisa L Flores, Tamil Arasu, PhD, Pratik S Upadhyay, DDC
Hetero Labs Limited (Warehouse) [Nakkapalle / India]
Inspection End Date: September 26, 2025
FEI: 3040501127
Location: NAKKAPALLE, ANDHRA PRADESH, India
Investigators: Guerlain Ulysse, Constance L Richard
Baxter Oncology GmbH [Halle (Westfalen) / Germany]
Inspection End Date: September 26, 2025
FEI: 3002806419
Location: HALLE (WESTFALEN), NORDRHEIN-WESTFALEN, Germany
Investigators: Justin A Boyd, Vivin George, Karen A Briggs
Honour Lab Limited [Nakkapalle / India]
Inspection End Date: September 26, 2025
FEI: 3010828439
Location: NAKKAPALLE, ANDHRA PRADESH, India
Investigators: Constance L Richard, Saleem A Akhtar, Rafeeq A Habeeb
SUAN FARMA INC [Fair Lawn / United States of America]
Inspection End Date: September 26, 2025
FEI: 3003273300
Location: FAIR LAWN, NEW JERSEY, United States of America
Investigators: Unnee Ranjan, Young K Chou
JW Nutritional LLC [Mckinney / United States of America]
Inspection End Date: September 26, 2025
FEI: 3031468435
Location: MCKINNEY, TEXAS, United States of America
Investigators: Milton J De Jesus Tavarez
VVF ILLINOIS SERVICES LLC [Montgomery / United States of America]
Inspection End Date: September 26, 2025
FEI: 1415660
Location: MONTGOMERY, ILLINOIS, United States of America
Investigators: Aerial A Smith
Nelson Laboratories, LLC [Itasca / United States of America]
Inspection End Date: September 26, 2025
FEI: 3000717698
Location: ITASCA, ILLINOIS, United States of America
Investigators: Bryan L Mcguckin, Angela C Welker
Patheon Pharmaceuticals Inc. [Cincinnati / United States of America]
Inspection End Date: September 26, 2025
FEI: 1510437
Location: CINCINNATI, OHIO, United States of America
Investigators: Wen Ning Chan (Sally), Paranthaman Senthamaraikannan
PRA International, LLC [Lenexa / United States of America]
Inspection End Date: September 26, 2025
FEI: 3009325162
Location: LENEXA, KANSAS, United States of America
Investigators: Chelsea W Lamm
Ionetix Corporation [Miami Beach / United States of America]
Inspection End Date: September 26, 2025
FEI: 3022114900
Location: MIAMI BEACH, FLORIDA, United States of America
Investigators: Joanne E King, Dorothy P Kramer
PETNET INDIANA LLC [Indianapolis / United States of America]
Inspection End Date: September 26, 2025
FEI: 3009015485
Location: INDIANAPOLIS, INDIANA, United States of America
Investigators: Andrew Le
Alcami Carolinas Corporation [Wilmington / United States of America]
Inspection End Date: September 26, 2025
FEI: 1049418
Location: WILMINGTON, NORTH CAROLINA, United States of America
Investigators: Saundrea A Munroe, Tammy T Brown
A&Z Pharmaceutical, Inc. [Hauppauge / United States of America]
Inspection End Date: September 26, 2025
FEI: 1000521505
Location: HAUPPAUGE, NEW YORK, United States of America
Investigators: Emmanuel T Donyina, Jose Ohernandez Guzman
Overhill Farms Inc [Vernon / United States of America]
Inspection End Date: September 26, 2025
FEI: 3003656849
Location: VERNON, CALIFORNIA, United States of America
Investigators: Desiree C Iya
Cosmetic Enterprises Ltd [Pacoima / United States of America]
Inspection End Date: September 26, 2025
FEI: 2025292
Location: PACOIMA, CALIFORNIA, United States of America
Investigators: Gloria E Andia
Patheon Manufacturing Services LLC [Greenville / United States of America]
Inspection End Date: September 26, 2025
FEI: 1018495
Location: GREENVILLE, NORTH CAROLINA, United States of America
Investigators: Sonya M Edmonds, Nicole E Knowlton, David A Acevedo Santana
Rhodes Pharmaceuticals L.P. [Wilson / United States of America]
Inspection End Date: September 26, 2025
FEI: 3008529213
Location: WILSON, NORTH CAROLINA, United States of America
Investigators: Yvins Dezan
Intercos America, Inc. [West Nyack / United States of America]
Inspection End Date: September 26, 2025
FEI: 3008472922
Location: WEST NYACK, NEW YORK, United States of America
Investigators: Jenny Sung
Lily C. Chao, M.D. [Los Angeles / United States of America]
Inspection End Date: September 25, 2025
FEI: 3023087883
Location: LOS ANGELES, CALIFORNIA, United States of America
Investigators: Veronica L Bush
MANA PRODUCTS, INC. [Long Island City / United States of America]
Inspection End Date: September 25, 2025
FEI: 2430738
Location: LONG ISLAND CITY, NEW YORK, United States of America
Investigators: Catherine O Lamptey
Nifty Labs Private Limited [Visakhapatnam / India]
Inspection End Date: September 25, 2025
FEI: 3007025492
Location: VISAKHAPATNAM, ANDHRA PRADESH, India
Investigators: Karishma G Gopaul, Clinton J Lott
Eurofins BioPharma Product Testing ENCO, LLC [Jacksonville / United States of America]
Inspection End Date: September 25, 2025
FEI: 3006067100
Location: JACKSONVILLE, FLORIDA, United States of America
Investigators: Oluwasefunmi Agbanigo
PPD Development, L.P. [Middleton / United States of America]
Inspection End Date: September 25, 2025
FEI: 2129896
Location: MIDDLETON, WISCONSIN, United States of America
Investigators: Beatrix D Hippe, Eric D Bowles, Jean Claude Garay
Mayo Clinic PET Radiochemistry Facility [Rochester / United States of America]
Inspection End Date: September 24, 2025
FEI: 3009119769
Location: ROCHESTER, MINNESOTA, United States of America
Investigators: Andrew Le
Specialty Minerals Incorporated [Adams / United States of America]
Inspection End Date: September 23, 2025
FEI: 1214544
Location: ADAMS, MASSACHUSETTS, United States of America
Investigators: Samir C Gala
SSM Health Care St. Louis DBA SSM St. Clare Health Center [Fenton / United States of America]
Inspection End Date: September 23, 2025
FEI: 1972829
Location: FENTON, MISSOURI, United States of America
Investigators: June P Page, Sarah M Gauna
Woodstock Sterile Solutions [Woodstock / United States of America]
Inspection End Date: September 23, 2025
FEI: 1419377
Location: WOODSTOCK, ILLINOIS, United States of America
Investigators: Adetutu M Gidado
SpecGx LLC [Raleigh / United States of America]
Inspection End Date: September 22, 2025
FEI: 1021320
Location: RALEIGH, NORTH CAROLINA, United States of America
Investigators: Yvins Dezan
Aerin Medical, Inc. [Sunnyvale / United States of America]
Inspection End Date: September 22, 2025
FEI: 3011625895
Location: SUNNYVALE, CALIFORNIA, United States of America
Investigators: Brittany D Mccracken
ProRx LLC [Exton / United States of America]
Inspection End Date: September 19, 2025
FEI: 3022250654
Location: EXTON, PENNSYLVANIA, United States of America
Investigators: Taichun Qin, PhD
Sun Pharmaceutical Medicare Limited [Halol / India]
Inspection End Date: September 19, 2025
FEI: 3002957541
Location: HALOL, GUJARAT, India
Investigators: Eileen A Liu, Claudia Mperez Kasmarski
Corey G. Anderson M.D. [Tempe / United States of America]
Inspection End Date: September 19, 2025
FEI: 3038143251
Location: TEMPE, ARIZONA, United States of America
Investigators: Dina A Tallman
Barbara Ann Karmanos Cancer Hospital [Detroit / United States of America]
Inspection End Date: September 19, 2025
FEI: 3009027673
Location: DETROIT, MICHIGAN, United States of America
Investigators: Andrew Le
PETNET SOLUTIONS, INC. [Hackensack / United States of America]
Inspection End Date: September 19, 2025
FEI: 3007044510
Location: HACKENSACK, NEW JERSEY, United States of America
Investigators: Annet R Rajan, Janet A Rajan, Young K Chou
Kent A. Swaine Md [Las Vegas / United States of America]
Inspection End Date: September 19, 2025
FEI: 3031441760
Location: LAS VEGAS, NEVADA, United States of America
Investigators: Scott N Lim
Farnam Companies Inc [Council Bluffs / United States of America]
Inspection End Date: September 19, 2025
FEI: 1000305328
Location: COUNCIL BLUFFS, IOWA, United States of America
Investigators: Pamela N Agaba, Lisa R Hilliar
Actavis Laboratories UT, Inc. [Salt Lake City / United States of America]
Inspection End Date: September 19, 2025
FEI: 1000117147
Location: SALT LAKE CITY, UTAH, United States of America
Investigators: Luis P Torres, Brittny C Cargo
Generics Bidco II LLC d/b/a Prinston Laboratories [Charlotte / United States of America]
Inspection End Date: September 19, 2025
FEI: 1038197
Location: CHARLOTTE, NORTH CAROLINA, United States of America
Investigators: Samantha E Cleek
Lights' Prosthetic Eyes Inc [Peoria / United States of America]
Inspection End Date: September 19, 2025
FEI: 3007096749
Location: PEORIA, ILLINOIS, United States of America
Investigators: Hammam A Abdallah
Myron L Company [Carlsbad / United States of America]
Inspection End Date: September 19, 2025
FEI: 2020976
Location: CARLSBAD, CALIFORNIA, United States of America
Investigators: Jenny L Chisem
Lianyungang Kangle Pharmaceutical Co., Ltd. [Lianyungang / China]
Inspection End Date: September 19, 2025
FEI: 3010728729
Location: LIANYUNGANG, JIANGSU, China
Investigators: Veronica Fuentes, MS
Syntech International, Inc [Irvine / United States of America]
Inspection End Date: September 19, 2025
FEI: 3005142514
Location: IRVINE, CALIFORNIA, United States of America
Investigators: Jordan I Abel
Crown Laboratories, Inc. [Johnson City / United States of America]
Inspection End Date: September 19, 2025
FEI: 1019820
Location: JOHNSON CITY, TENNESSEE, United States of America
Investigators: Inga M Warr
J.M. Murray Center, Inc. [Cortland / United States of America]
Inspection End Date: September 19, 2025
FEI: 1319147
Location: CORTLAND, NEW YORK, United States of America
Investigators: John D Mcintosh
Kazutomo Toyofuku [Shinjuku / Japan]
Inspection End Date: September 19, 2025
FEI: 3038548762
Location: SHINJUKU, KANAGAWA, Japan
Investigators: Lakecha N Lewis
Daane Labs [Naples / United States of America]
Inspection End Date: September 19, 2025
FEI: 3012440392
Location: NAPLES, FLORIDA, United States of America
Investigators: Kayla V Sprague
Immacule Lifesciences Private Limited [Nalagarh / India]
Inspection End Date: September 18, 2025
FEI: 3014210753
Location: NALAGARH, HIMACHAL PRADESH, India
Investigators: José E Meléndez, Angelica M Hernandez, Damaris Y Hernandez
Solaris Pharma Corporation [Bridgewater / United States of America]
Inspection End Date: September 18, 2025
FEI: 3012158090
Location: BRIDGEWATER, NEW JERSEY, United States of America
Investigators: Brandy D Brown
BAXALTA US INC. [Newbury Park / United States of America]
Inspection End Date: September 18, 2025
FEI: 1000519965
Location: NEWBURY PARK, CALIFORNIA, United States of America
Investigators: Alan L Truong, Gene D Arcy
Petscript Inc. [Paris / United States of America]
Inspection End Date: September 18, 2025
FEI: 3010282564
Location: PARIS, TEXAS, United States of America
Investigators: Margaret M Annes, Katherine M Breed
Division of Nuclear Medicine PET Radiopharmaceutical Production Program [Ann Arbor / United States of America]
Inspection End Date: September 17, 2025
FEI: 3010166888
Location: ANN ARBOR, MICHIGAN, United States of America
Investigators: Andrew Le
Intas Pharmaceuticals Limited [Vikasnagar / India]
Inspection End Date: September 17, 2025
FEI: 3005890633
Location: VIKASNAGAR, UTTARAKHAND, India
Investigators: Tamil Arasu, PhD, Saleem A Akhtar
Eurofins Food Chemistry Testing Madison Inc. [Madison / United States of America]
Inspection End Date: September 17, 2025
FEI: 3017522935
Location: MADISON, WISCONSIN, United States of America
Investigators: Lori B Wikstrom
Quotient Sciences - Philadelphia, LLC [Marcus Hook / United States of America]
Inspection End Date: September 17, 2025
FEI: 3003882011
Location: MARCUS HOOK, PENNSYLVANIA, United States of America
Investigators: Ruben C Quintana, Anastasia M Shields
Lan Luo M.D. [Ocala / United States of America]
Inspection End Date: September 16, 2025
FEI: 3038258929
Location: OCALA, FLORIDA, United States of America
Investigators: Chinyere A Asanya
LUPIN LIMITED [Nagpur / India]
Inspection End Date: September 16, 2025
FEI: 3015392060
Location: NAGPUR, MAHARASHTRA, India
Investigators: Hung H Do, MS, Chad W Rice, Sandra A Boyd
Fareva Amboise [Pocé-Sur-Cisse / France]
Inspection End Date: September 16, 2025
FEI: 3000234005
Location: POCÉ-SUR-CISSE, CENTRE-VAL DE LOIRE, France
Investigators: Justin A Boyd, Vivin George, Karen A Briggs
Microbiological Testing & Consulting, LLC [Chicago / United States of America]
Inspection End Date: September 16, 2025
FEI: 3003875820
Location: CHICAGO, ILLINOIS, United States of America
Investigators: Nicholas P Diorio, Travis V Hull
Amgen Technology (ireland) Unlimited Company [Dun Laoghaire / Ireland]
Inspection End Date: September 16, 2025
FEI: 3002808497
Location: DUN LAOGHAIRE, DUBLIN, Ireland
Investigators: Wayne E Seifert
Pillar Biosciences Inc. [Natick / United States of America]
Inspection End Date: September 16, 2025
FEI: 3016560486
Location: NATICK, MASSACHUSETTS, United States of America
Investigators: James P Finn
Unilever Manufacturing (US), Inc. [Jonesboro / United States of America]
Inspection End Date: September 15, 2025
FEI: 3006642851
Location: JONESBORO, ARKANSAS, United States of America
Investigators: Thuy T Nguyen, LCDR
ChiRhoClin, Inc [Burtonsville / United States of America]
Inspection End Date: September 15, 2025
FEI: 3003194366
Location: BURTONSVILLE, MARYLAND, United States of America
Investigators: Claude Noel Y Zanetsie, Catherine O Lamptey, Pushpa Suresh Jayasekara
Pharbest Pharmaceuticals, Inc. [Farmingdale / United States of America]
Inspection End Date: September 15, 2025
FEI: 3005382247
Location: FARMINGDALE, NEW YORK, United States of America
Investigators: Luxuly Abraham
Anish Shah, M.D. [Santa Rosa / United States of America]
Inspection End Date: September 15, 2025
FEI: 3023890987
Location: SANTA ROSA, CALIFORNIA, United States of America
Investigators: Dustin R Abaonza, Linh T Tu
DR. REDDY'S LABORATORIES LTD [Uppal / India]
Inspection End Date: September 12, 2025
FEI: 3014250111
Location: UPPAL, TELANGANA, India
Investigators: Madushini Dharmasena, PhD, Jiangsong Jiang, Baikuntha Aryal, PhD
IMMUNOLOGIX LABORATORIES [Tampa / United States of America]
Inspection End Date: September 12, 2025
FEI: 3014849191
Location: TAMPA, FLORIDA, United States of America
Investigators: Erin M Mcdowell, Hugh M Mcclure, II
Aaron C. Ermel, MD [Indianapolis / United States of America]
Inspection End Date: September 12, 2025
FEI: 3039047652
Location: INDIANAPOLIS, INDIANA, United States of America
Investigators: Victoria R Flournoy
Rush University Medical Center IRB [Chicago / United States of America]
Inspection End Date: September 12, 2025
FEI: 3001770544
Location: CHICAGO, ILLINOIS, United States of America
Investigators: Chelsea W Lamm, Yuanyuan Li
Higley Industries, Inc. [Dyersville / United States of America]
Inspection End Date: September 12, 2025
FEI: 3002984417
Location: DYERSVILLE, IOWA, United States of America
Investigators: Monica E Murie
Sharp Packaging Services, LLC [Macungie / United States of America]
Inspection End Date: September 12, 2025
FEI: 3009566827
Location: MACUNGIE, PENNSYLVANIA, United States of America
Investigators: Kara J Wright
Arch Pharmalabs Limited [Dombivli / India]
Inspection End Date: September 12, 2025
FEI: 3002808114
Location: DOMBIVLI, MAHARASHTRA, India
Investigators: Christopher R Czajka
Cardinal Health 414, LLC [Indianapolis / United States of America]
Inspection End Date: September 12, 2025
FEI: 3012101967
Location: INDIANAPOLIS, INDIANA, United States of America
Investigators: Rowena S Nguyen, Carolina D Vasquez
Cosmax Usa, Corporation [Carteret / United States of America]
Inspection End Date: September 12, 2025
FEI: 3002679704
Location: CARTERET, NEW JERSEY, United States of America
Investigators: Christian F Gomez Lugo
Zhejiang Shenzhou Pharmaceutical Co., Ltd. [Xianju / China]
Inspection End Date: September 12, 2025
FEI: 3005463252
Location: XIANJU, ZHEJIANG, China
Investigators: Patty P Kaewussdangkul
WestRock Converting, LLC [Ridgeway / United States of America]
Inspection End Date: September 12, 2025
FEI: 3003075526
Location: RIDGEWAY, VIRGINIA, United States of America
Investigators: Nelson N Ayangho, Syeda N Mahazabin
Xenova Sciences, LLC [Gretna / United States of America]
Inspection End Date: September 12, 2025
FEI: 3025324933
Location: GRETNA, NEBRASKA, United States of America
Investigators: Lisa R Hilliar
Best Buy Bones Inc. [Mount Morris / United States of America]
Inspection End Date: September 12, 2025
FEI: 3011800162
Location: MOUNT MORRIS, MICHIGAN, United States of America
Investigators: Christi L Bellmore
Avadel CNS Pharmaceuticals, LLC [Chesterfield / United States of America]
Inspection End Date: September 12, 2025
FEI: 3012841301
Location: CHESTERFIELD, MISSOURI, United States of America
Investigators: Courtney R Bratina
Shire Human Genetic Therapies, Inc. [Cambridge / United States of America]
Inspection End Date: September 12, 2025
FEI: 3005955297
Location: CAMBRIDGE, MASSACHUSETTS, United States of America
Investigators: Jessica S Estriplet, Lori M Newman, Bijoy Panicker
Merck Sharp & Dohme LLC [Wilson / United States of America]
Inspection End Date: September 12, 2025
FEI: 1036761
Location: WILSON, NORTH CAROLINA, United States of America
Investigators: Mabany Lizardi, Megan T Ziegler, Santos E Camara
Ningxia Qiyuan Pharmaceutical Co., Ltd. [Wangyuan / China]
Inspection End Date: September 12, 2025
FEI: 3004341367
Location: WANGYUAN, HUI AUTONOMOUS REGION OF NINGXIA, China
Investigators: Evan Tong, Victoria Spivak
BioLyte Laboratories, LLC [Grand Rapids / United States of America]
Inspection End Date: September 12, 2025
FEI: 3013171766
Location: GRAND RAPIDS, MICHIGAN, United States of America
Investigators: Joohi Castelvetere, Elizabeth R Bloom
Ajinomoto Health & Nutrition North America Inc [Eddyville / United States of America]
Inspection End Date: September 12, 2025
FEI: 3003918018
Location: EDDYVILLE, IOWA, United States of America
Investigators: Nibin Varghese, MS, Ramia Brzenjy
Eli Lilly and Company [Kenosha / United States of America]
Inspection End Date: September 11, 2025
FEI: 3031961517
Location: KENOSHA, WISCONSIN, United States of America
Investigators: Melissa M Steiger, Jacob G Lutz, Tianhong Zhou
Unette Corporation [Randolph / United States of America]
Inspection End Date: September 11, 2025
FEI: 2210679
Location: RANDOLPH, NEW JERSEY, United States of America
Investigators: Michael O Idowu
Areva Pharmaceuticals Inc [Georgetown / United States of America]
Inspection End Date: September 11, 2025
FEI: 3009960162
Location: GEORGETOWN, INDIANA, United States of America
Investigators: Iris C Macinnes
OXYGEN DEVELOPMENT, L.L.C. [West Palm Beach / United States of America]
Inspection End Date: September 11, 2025
FEI: 3009461317
Location: WEST PALM BEACH, FLORIDA, United States of America
Investigators: Alan A Rivera
Boehringer Ingelheim Pharmaceuticals, Inc. [Ridgefield / United States of America]
Inspection End Date: September 11, 2025
FEI: 1219205
Location: RIDGEFIELD, CONNECTICUT, United States of America
Investigators: Kent A Conforti
Tropichem Research Labs, LLC dba Vetio [Jupiter / United States of America]
Inspection End Date: September 11, 2025
FEI: 1000113165
Location: JUPITER, FLORIDA, United States of America
Investigators: Daniel L Zheng
Precision Optics Corporation, Inc. [Gardner / United States of America]
Inspection End Date: September 11, 2025
FEI: 1000120916
Location: GARDNER, MASSACHUSETTS, United States of America
Investigators: Jeffrey J Thibodeau
Precision Dose Inc. [South Beloit / United States of America]
Inspection End Date: September 11, 2025
FEI: 1419861
Location: SOUTH BELOIT, ILLINOIS, United States of America
Investigators: Ngozi G Offor
JHK Inc dba American Safety & First Aid [Osceola / United States of America]
Inspection End Date: September 11, 2025
FEI: 3003304148
Location: OSCEOLA, INDIANA, United States of America
Investigators: Muna Algharibeh
MSD International GmbH (Puerto Rico Branch) LLC [Montones / Puerto Rico]
Inspection End Date: September 10, 2025
FEI: 2650155
Location: MONTONES, PUERTO RICO, Puerto Rico
Investigators: Jose Velez, Marian E Ramirez
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