Recently Published FDA Form 483s
Lynch Biologics LLC [Franklin / United States of America]
Inspection End Date: July 2, 2024
FEI: 3011175224
Location: FRANKLIN, TENNESSEE, United States of America
Investigators: Jamie P Webb
LGM PHARMA, LLC [Erlanger / United States of America]
Inspection End Date: June 28, 2024
FEI: 3012048333
Location: ERLANGER, KENTUCKY, United States of America
Investigators: Logan T Williams
Hikma Injectables USA Inc. [Dayton / United States of America]
Inspection End Date: June 25, 2024
FEI: 3022897129
Location: DAYTON, NEW JERSEY, United States of America
Investigators: Luxuly Abraham, Ogechi C Nna, Edmund F Mrak, Jr
Cipla Ltd. [Gounlloy / India]
Inspection End Date: June 21, 2024
FEI: 3004081307
Location: GOUNLLOY, GOA, India
Investigators: Joseph A Piechocki, Eileen A Liu, Tamil Arasu, PhD
Right Value Drug Stores, LLC dba Carie Boyd's Prescription Shop [Irving / United States of America]
Inspection End Date: June 21, 2024
FEI: 3010589333
Location: IRVING, TEXAS, United States of America
Investigators: Camerson E Moore
Masterbilt Incorporated [South Bend / United States of America]
Inspection End Date: June 21, 2024
FEI: 3000203601
Location: SOUTH BEND, INDIANA, United States of America
Investigators: Suyang Qin
BIOCON BIOSPHERE LIMITED [Paravada / India]
Inspection End Date: June 14, 2024
FEI: 3022125340
Location: PARAVADA, ANDHRA PRADESH, India
Investigators: Brandy N Lepage
Torrent Pharmaceuticals Limited [Kadi / India]
Inspection End Date: June 12, 2024
FEI: 3005029956
Location: KADI, GUJARAT, India
Investigators: Steven A Brettler, Pratik S Upadhyay, DDC
Verdesian Life Sciences [North Lima / United States of America]
Inspection End Date: June 12, 2024
FEI: 3003827375
Location: NORTH LIMA, OHIO, United States of America
Investigators: Lisa M Marko
Hikma Pharmaceuticals USA Inc. [Cherry Hill / United States of America]
Inspection End Date: June 12, 2024
FEI: 2220525
Location: CHERRY HILL, NEW JERSEY, United States of America
Investigators: Christian F Gomez Lugo, Azeezat M Lawal, Yoriann M Cabrera Bartolomei, Christina K Theodorou
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
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
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
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
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
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
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
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
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
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
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
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
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
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
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
Americold Logistics [Sumter / United States of America]
Inspection End Date: May 7, 2024
FEI: 3008450593
Location: SUMTER, SOUTH CAROLINA, United States of America
Investigators: Katelynn J Rollins
East Bay Wholesales Corporation [Philadelphia / United States of America]
Inspection End Date: May 6, 2024
FEI: 3015329614
Location: PHILADELPHIA, PENNSYLVANIA, United States of America
Investigators: Nicholas J Morici
Advance Food International Inc. [Maspeth / United States of America]
Inspection End Date: May 6, 2024
FEI: 3001232235
Location: MASPETH, NEW YORK, United States of America
Investigators: Sarah K Graham
Bonafide Innovations LLC [Irving / United States of America]
Inspection End Date: May 6, 2024
FEI: 3013929870
Location: IRVING, TEXAS, United States of America
Investigators: Kevin T Nguyen
Bloodworks [Seattle / United States of America]
Inspection End Date: May 3, 2024
FEI: 3071347
Location: SEATTLE, WASHINGTON, United States of America
Investigators: Kaarin M Slotte, Sunitha K Rajaram, PhD
San Diego Eye Bank [San Diego / United States of America]
Inspection End Date: May 3, 2024
FEI: 3002515992
Location: SAN DIEGO, CALIFORNIA, United States of America
Investigators: Melsomar R Ramos, Shelley H Beausoleil
Solevy Co. LLC [Valencia / United States of America]
Inspection End Date: May 3, 2024
FEI: 3016842367
Location: VALENCIA, CALIFORNIA, United States of America
Investigators: Sara H Gabel
Tissue Transplant Technology, Ltd. [San Antonio / United States of America]
Inspection End Date: May 3, 2024
FEI: 3000779542
Location: SAN ANTONIO, TEXAS, United States of America
Investigators: Maira P Brading, Michael A Blaine
Mara Piltin, D.O. [Rochester / United States of America]
Inspection End Date: May 3, 2024
FEI: 3027966785
Location: ROCHESTER, MINNESOTA, United States of America
Investigators: Denise L Burosh
SOUTH SWELL TRADING COMPANY [El Segundo / United States of America]
Inspection End Date: May 3, 2024
FEI: 3013833392
Location: EL SEGUNDO, CALIFORNIA, United States of America
Investigators: Brandon R Boone
American Behavioral Research Institute, LLC [Boca Raton / United States of America]
Inspection End Date: May 3, 2024
FEI: 3030358101
Location: BOCA RATON, FLORIDA, United States of America
Investigators: Sheri L Stephenson
ALI Pharmaceutical Manufacturing, LLC [Omaha / United States of America]
Inspection End Date: May 3, 2024
FEI: 1920841
Location: OMAHA, NEBRASKA, United States of America
Investigators: Monica E Murie
EUGIA PHARMA SPECIALITIES LIMITED [Bhiwadi / India]
Inspection End Date: May 3, 2024
FEI: 3009883410
Location: BHIWADI, RAJASTHAN, India
Investigators: Justin A Boyd, Anastasia M Shields, Vaishali J Patel
Willow Birch Pharma Inc [Taylor / United States of America]
Inspection End Date: May 3, 2024
FEI: 3009864247
Location: TAYLOR, MISSISSIPPI, United States of America
Investigators: Megan T Ziegler, Demario L Walls
Kinetics Derma Beauty, L.L.C [Sugar Land / United States of America]
Inspection End Date: May 3, 2024
FEI: 3015841037
Location: SUGAR LAND, TEXAS, United States of America
Investigators: Timothy H Vo
GSB LLC [Nashville / United States of America]
Inspection End Date: May 3, 2024
FEI: 3013726944
Location: NASHVILLE, TENNESSEE, United States of America
Investigators: Nikki S Bryant
General Hearing Instruments Inc [New Orleans / United States of America]
Inspection End Date: May 3, 2024
FEI: 2317393
Location: NEW ORLEANS, LOUISIANA, United States of America
Investigators: Nydia E Colon
Novant Health Forsyth Medical Center [Winston Salem / United States of America]
Inspection End Date: May 2, 2024
FEI: 1037588
Location: WINSTON SALEM, NORTH CAROLINA, United States of America
Investigators: Randy L Clarida
FMT Services, LLC [Grand Prairie / United States of America]
Inspection End Date: May 2, 2024
FEI: 3012256793
Location: GRAND PRAIRIE, TEXAS, United States of America
Investigators: Karen V Nguyen, Long Q Phan
Morningstar Minerals LLC [Farmington / United States of America]
Inspection End Date: May 2, 2024
FEI: 3008096549
Location: FARMINGTON, NEW MEXICO, United States of America
Investigators: Charles B Steinmiller
WuXi AppTec Inc. [Marietta / United States of America]
Inspection End Date: May 2, 2024
FEI: 1000511606
Location: MARIETTA, GEORGIA, United States of America
Investigators: Tammara A Stephens, Leslie W Gilbert
United Therapeutics Corporation [Silver Spring / United States of America]
Inspection End Date: May 2, 2024
FEI: 3003368324
Location: SILVER SPRING, MARYLAND, United States of America
Investigators: Mindy M Chou, Annet R Rajan, Janet A Rajan
Nestle Purina Pet Care Co. [Clinton / United States of America]
Inspection End Date: May 2, 2024
FEI: 1924965
Location: CLINTON, IOWA, United States of America
Investigators: Joseph R Haynes, Andrew K Schaal
The Center For Human Reproduction d.b.a. American Infertility of New York, P.C. [New York / United States of America]
Inspection End Date: May 1, 2024
FEI: 3003969128
Location: NEW YORK, NEW YORK, United States of America
Investigators: Irina Gaberman
Gold Coast United, Inc. [Elkridge / United States of America]
Inspection End Date: May 1, 2024
FEI: 3003710652
Location: ELKRIDGE, MARYLAND, United States of America
Investigators: Lisa R Heath, Mohamad A Chahine
Eclipse Technology Solutions Inc [Chadds Ford / United States of America]
Inspection End Date: May 1, 2024
FEI: 3023517782
Location: CHADDS FORD, PENNSYLVANIA, United States of America
Investigators: Kish Bolden
Legend Aerospace, Inc. [Miami / United States of America]
Inspection End Date: May 1, 2024
FEI: 3003770530
Location: MIAMI, FLORIDA, United States of America
Investigators: Matthew T Sanchez, Ronald Ifraimov
Sterling Pharmaceutical Services, LLC [East Carondelet / United States of America]
Inspection End Date: May 1, 2024
FEI: 3009705561
Location: EAST CARONDELET, ILLINOIS, United States of America
Investigators: Melissa M Steiger, Mary L Schuckmann, José E Meléndez
Pos-T-Vac, Inc. [Dodge City / United States of America]
Inspection End Date: April 30, 2024
FEI: 1931563
Location: DODGE CITY, KANSAS, United States of America
Investigators: Eric C Fox
INTERFRESH, INC. [Orange / United States of America]
Inspection End Date: April 30, 2024
FEI: 3012433328
Location: ORANGE, CALIFORNIA, United States of America
Investigators: Anthony E Guzman
SOHGAVE LLC [Dallas / United States of America]
Inspection End Date: April 30, 2024
FEI: 3015106322
Location: DALLAS, TEXAS, United States of America
Investigators: Katherine D Cogburn Perez
KSE Scientific LLC [Durham / United States of America]
Inspection End Date: April 30, 2024
FEI: 3007080588
Location: DURHAM, NORTH CAROLINA, United States of America
Investigators: Christopher B May
Avatar Foods Inc [Henderson / United States of America]
Inspection End Date: April 29, 2024
FEI: 3012729600
Location: HENDERSON, NEVADA, United States of America
Investigators: Jorge L Bertran, Yen Tso Kuo, Ngoc B Kelsch, Angelica Ornelas
Alpha Orthopedic Systems, LLC [Louisville / United States of America]
Inspection End Date: April 29, 2024
FEI: 3010292869
Location: LOUISVILLE, KENTUCKY, United States of America
Investigators: Jennifer L Sheehan
WakeMed IRB [Raleigh / United States of America]
Inspection End Date: April 29, 2024
FEI: 1049716
Location: RALEIGH, NORTH CAROLINA, United States of America
Investigators: Anthony J Grace
Regional Women's Health Group, LLC [Marlton / United States of America]
Inspection End Date: April 29, 2024
FEI: 3004088908
Location: MARLTON, NEW JERSEY, United States of America
Investigators: Emily A Walters
Rapid Oxygen Inc. [Shelton / United States of America]
Inspection End Date: April 26, 2024
FEI: 3014408327
Location: SHELTON, CONNECTICUT, United States of America
Investigators: Katarzyna Plona
Medas, Inc. [Miami / United States of America]
Inspection End Date: April 26, 2024
FEI: 3012050423
Location: MIAMI, FLORIDA, United States of America
Investigators: Tyler R Courtney, Marvin A Marenco
Patrick S. Kamath, M.D., Clinical Investigator [Rochester / United States of America]
Inspection End Date: April 26, 2024
FEI: 3030383372
Location: ROCHESTER, MINNESOTA, United States of America
Investigators: Sharon L Matson
Mid South Precision, Inc. [Murfreesboro / United States of America]
Inspection End Date: April 26, 2024
FEI: 3011189525
Location: MURFREESBORO, TENNESSEE, United States of America
Investigators: Jamie P Webb
Key Foods Co. dba Key Food Services [Alsip / United States of America]
Inspection End Date: April 25, 2024
FEI: 3006254263
Location: ALSIP, ILLINOIS, United States of America
Investigators: Lesley A Swanson, Alcee M Tavarez
MARS Petcare US , Inc. [Sparks / United States of America]
Inspection End Date: April 25, 2024
FEI: 3004395098
Location: SPARKS, NEVADA, United States of America
Investigators: Kenneth G Klobus, James A Barreto
Polygon Medical, Inc. [Holliston / United States of America]
Inspection End Date: April 25, 2024
FEI: 3014407293
Location: HOLLISTON, MASSACHUSETTS, United States of America
Investigators: James P Finn
Dorel Juvenile Group, Inc. [Columbus / United States of America]
Inspection End Date: April 25, 2024
FEI: 1000137876
Location: COLUMBUS, INDIANA, United States of America
Investigators: Melina Lrodriguez Upton
Spectra Medical Devices, LLC [Wilmington / United States of America]
Inspection End Date: April 25, 2024
FEI: 3000204727
Location: WILMINGTON, MASSACHUSETTS, United States of America
Investigators: Nabil Nakhoul
Central Indiana Ethanol [Marion / United States of America]
Inspection End Date: April 24, 2024
FEI: 3008674328
Location: MARION, INDIANA, United States of America
Investigators: Muna Algharibeh
American Regent, Inc. [Shirley / United States of America]
Inspection End Date: April 24, 2024
FEI: 2410375
Location: SHIRLEY, NEW YORK, United States of America
Investigators: Edmund F Mrak, Jr, Bijoy Panicker
I am working in QA department of Pharmaceutical company, I am updating myself about FDA requirements.