FDA Form 483 Records
Browse through 15,192 fda form 483 records and compliance documents. Access detailed regulatory information to stay informed about industry trends and compliance requirements.
Showing 20 of 15,192 records
Catalent Indiana, LLC
Product: drugs
Office: FDA District Office — Detroit, Michigan
People: Joohi Castelvetere, Robert J. Ham (Investigator?), Brandy N. Lepage (Consumer Safety Officer)
Lonza Biologics, Inc.
Product: drugs
Office: New England District Office
People: Christian D. Lynch (investigator), Laurel A. Beer
National Railroad Passenger Corporation (Amtrak)
Product: Devices
Office: Baltimore District Office
People: Austin B. Appler
Fresh & Ready Foods LLC
Product: Food
Office: Los Angeles District Office
People: Emily D. Lam, Greg K. Keshishyan (investigator), Darrin E. Davis
Chemspec Chemicals Private Limited
Product: Drugs
Office: Office of Inspections and Investigations
People: Paranthaman SenthamaraiKannan, Investigator, Tamil Arasu (Consumer Safety Officer - Dedicated Foreign Drug Cadre)
Aquavit Life Sciences, Inc.
Product: devices
Office: New York District Office
People: Colin E. Tack, Jacqueline S. Warner
Darmerica, LLC
Product: drugs
Office: Florida District Office
People: Mabany Lizardi, Investigator (FDA_PERSONNEL), Joanne E. King, Investigator, Marian E. Ramirez - Investigator
Immacule Lifesciences Private Limited
Product: drugs
Office: Office of Inspections and Investigations
People: Nicole E. Knowlton (Investigator )
Joinn Laboratories Co., Ltd.
Product: drugs
Office: Office of Inspections and Investigations
People: Niraj R. Mehta (investigator), Zhou Chen, Lead Pharmacologist, Francis J. Eng
Lupin Limited
Product: Drugs
Office: Office of Inspections and Investigations
People: Mark L. Baum, Maria T. Bradfish (company_representative), Gregory Stone
Qilu Pharmaceutical Co., Ltd. (Dongjia Site)
Product: drugs
Office: Office of Inspections and Investigations
People: Junho Pak (Investigator)
Daiichi Sankyo Chemical Pharma Co., Ltd.
Product: drugs
Office: Office of Inspections and Investigations
People: Thuy T. Nguyen ( Investigator, Consumer Safety Officer), Jun Liu
MSD Ireland (Carlow)
Product: biologics
Office: Office of Inspections and Investigations
People: Michael R. Shanks, Senior Biologist, Ralph M. Bernstein, Jennifer E. Veenhof
Meiji Seika Pharma Co., Ltd.
Product: drugs
Office: Office of Inspections and Investigations
People: Teresa I. Navas
AMKS TIME RELEASE LAB, LLC
Product: drugs
Office: New Jersey District Office
People: Ismail Elchagea (company_representative), Peter R. Lenahan (Regulatory Officer)
Abbvie Biotechnology Ltd.
Product: Drugs
Office: San Juan District Office
People: Jose E. Melendez (Quality System Specialist)
McPherson Enterprises, Inc., dba Implantable Devices
Product: devices
Office: Florida District Office
People: Alex J. Wild
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