Untitled Letter Records
Browse through 98 untitled letter records and compliance documents. Access detailed regulatory information to stay informed about industry trends and compliance requirements.
Showing 20 of 98 records
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: Joseph Bagan (Chief Executive Officer), Frances G. Bormel (Director)
Violations: 5 code(s)
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 I
People: Steven E. Porter (Program Division Director), Lance M. De Souza (Director - Compliance Branch)
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 IV
People: 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)
Valgene, Incorporated dba Cape Drugs
Product: Devices
Jubilant Draximage Radiopharmacies Inc
Product: Drugs
Office: Division of Pharmaceutical Quality Operations I
People: Joseph M. Huber, Marc Pfefferle, Eric M. Mueller
Violations: 5 code(s)
Product: Drugs
Office: Division of Pharmaceutical Quality Operations I
People: Steven E. Porter (Program Division Director), William V. Millar (Self-employed), Karen L. Muir (Ms.)
Violations: 5 code(s)
Arnold Professional Pharmacy
Product: Drugs
Office: Office of Pharmaceutical Quality
People: Stephanie Durso (Director of Compliance Branch_x000D_), Neil P. McGarvey, Diana Amador-Toro (District Director)
Violations: 3 code(s)
Maag Prescription Center LLC
Product: Drugs
Office: Division of Pharmaceutical Quality Operations I
People: Gregory A. Maag, Steven E. Porter (Program Division Director), Maria Kelly-doggett
Violations: 5 code(s)
BayCare Integrated Service Center LLC
Product: Drugs
Office: Office of Pharmaceutical Quality
People: Kenneth G. Jozefczyk, Renee Alsobrook, Dayna Martinez (Senior Compliance Officer)
Violations: 5 code(s)
Central Admixture Pharmacy Services, Inc.
Product: Drugs
Office: Office of Pharmaceutical Quality
People: Malcom Broussard, José R. Lopez (Program Expert), Thomas J. (Regulatory Counsel)
Violations: 5 code(s)
Stokes Healthcare Inc. dba Epicur Pharma
Product: Devices
Office: Center for Devices and Radiological Health
People: Juan Jiménez (Compliance Officer), Michael E. Marcarelli, Lisa M. Harlan (Program Division Director)
Violations: 5 code(s)
Wells Pharmacy, Inc
Product: Drugs
Office: Office of Pharmaceutical Quality
People: Rebecca A. Asente (Compliance Officer), Jason McLaren, Melissa Stefko
Violations: 5 code(s)
LEESAR, INC
Product: Drugs
Office: Office of Pharmaceutical Quality
People: James R. Boswell, José R. Lopez (Program Expert), Mark W. Rivero (Compliance Officer)
Violations: 5 code(s)
Davis City Pharmacy Inc.
Product: Drugs
Office: Office of Pharmaceutical Quality
People: Dayna Martinez (Senior Compliance Officer), Shawn E. Larson (Development Coordinator), Brandi M. Chane-lee
Violations: 5 code(s)
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