Untitled Letter Records
Browse through 100 untitled letter records and compliance documents. Access detailed regulatory information to stay informed about industry trends and compliance requirements.
Showing 20 of 100 records
Denver Solutions, LLC DBA Leiters Health
Office: Center for Drug Evaluation and Research
People: Matthew J. Lash (Acting Director)
Violations: 4 code(s)
Molecular PharmaGroup
Office: Office of Pharmaceutical Quality
People: Matthew J. Lash (Acting Director)
Violations: 5 code(s)
LEESAR, INC
Product: Drugs
Office: Office of Compounding Quality and Compliance
People: F. Gail Bormel (F.)
Violations: 5 code(s)
STAQ Pharma of Ohio, LLC
Office: Center for Drug Evaluation and Research
People: Frances G. Bormel (Director), Joseph Bagan (Chief Executive Officer)
Violations: 5 code(s)
Sincerus Florida, LLC dba SKNV
Product: Drugs
Office: Office of Compounding Quality and Compliance
People: Frances G. Bormel (Director)
Violations: 5 code(s)
Wells Pharmacy, Inc
Product: Drugs
Office: Office of Compounding Quality and Compliance
People: Frances G. Bormel (Director)
Violations: 2 code(s)
QuVa Pharma, Inc.
Product: Drugs
Office: Center for Drug Evaluation and Research
People: Frances G. Bormel (Director)
Violations: 5 code(s)
Wedgewood Connect, LLC
Product: Drugs
Office: Division of Pharmaceutical Quality Operations IV
People: Lance M. De Souza (Director - Compliance Branch)
Valgene, Incorporated dba Cape Drugs
Product: Devices
Wedgewood Pharmacy LLC
Product: Drugs
Office: Division of Pharmaceutical Quality Operations III
People: Rebecca E. Dowd (Director of Investigations Branch)
Wedgewood Connect, LLC
Product: Drugs
Office: Division of Pharmaceutical Quality Operations I
People: Steven E. Porter (Program Division Director), Lance M. De Souza (Director - Compliance Branch)
Wedgewood Connect, LLC
Product: Drugs
Office: Division of Pharmaceutical Quality Operations IV
People: Lance M. De Souza (Director - Compliance Branch)
Jubilant Draximage Radiopharmacies Inc
Product: Drugs
Office: Division of Pharmaceutical Quality Operations I
People: Nicholas F. Lyons (Director of Compliance), Joseph M. Huber, Marc Pfefferle
Violations: 5 code(s)
Record cda8816a
Product: Drugs
Office: Division of Pharmaceutical Quality Operations I
People: Steven E. Porter (Program Division Director), Karen L. Muir (Ms.), William V. Millar (Self-employed)
Violations: 5 code(s)
Arnold Professional Pharmacy
Product: Drugs
Office: Office of Pharmaceutical Quality
People: Diana Amador-Toro (District Director), Craig W. Swanson (Deputy District Director), Neil P. McGarvey
Violations: 3 code(s)
Maag Prescription Center LLC
Product: Drugs
Office: Division of Pharmaceutical Quality Operations I
People: Steven E. Porter (Program Division Director), Gregory A. Maag, Maria Kelly-doggett
Violations: 5 code(s)
BayCare Integrated Service Center LLC
Product: Drugs
Office: Office of Pharmaceutical Quality
People: William S. Boivin (Retired at FDA), John W. Diehl (John W. Diehl, M.S.Program Division), Kenneth G. Jozefczyk
Violations: 5 code(s)
Central Admixture Pharmacy Services, Inc.
Product: Drugs
Office: Office of Pharmaceutical Quality
People: Thomas J. (Regulatory Counsel), José R. Lopez (Program Expert), Malcom Broussard
Violations: 5 code(s)
Stokes Healthcare Inc. dba Epicur Pharma
Product: Devices
Office: Center for Devices and Radiological Health
People: Lisa M. Harlan (Program Division Director), Michael E. Marcarelli, Juan Jiménez (Compliance Officer)
Violations: 5 code(s)
Wells Pharmacy, Inc
Product: Drugs
Office: Office of Pharmaceutical Quality
People: José R. Lopez (Program Expert), Kristopher Fishman, Jason McLaren
Violations: 5 code(s)
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