Enforcement Posts
Internal Audit Reports: Can the FDA Take a Peek? Part 2: Other Agencies
Expert Commentary | China Updates Clinical Trial Guidance on “Safety Information Assessment and Risk Management Work Procedures”
Expert Commentary | Updates to FDA’s Manual of Policies and Procedures (MAPP)
Expert Commentary: FY2022 Report on the State of Pharmaceutical Quality
Internal Audit Reports: Can the FDA Take a Peek?
FDA Issues 38-Page 483 to Solid Oral Dosage Manufacturer
OTC Skincare Firm Receives Warning Letter Due to CGMP Concerns
FDA Warning Letters: 11/22/2020 & 12/1/2020
FDA Warning Letters Week Of 11/8/2020: Process Validation Failures
Warning Letters Week Of 11/1/2020: Hold Times
Warning Letters Week Of 10/25/2020: Cleaning Validation
Warning Letters Week Of 10/18/2020: Misbranded Biologics
Warning Letters Week Of 10/11/2020: Unauthorized Cell Therapy
Warning Letters 10/4/2020: Medical Device Adverse Events
Q2 2020 Food and Dietary Supplement Warning Letters
Warning Letters Week Of 9/27/2020: Aseptic Process Issues
Warning Letters Week Of 9/20/2020: Quality Unit Failures
Warning Letters Week Of 9/13/2020: Lack of Validation
Highlights from Recent FDA Inspections of Vendors/Suppliers
Warning Letters Week Of 9/6/2020: Data Integrity Failures
Warning Letters Week of 8/30/2020: Adulterated Products
Warning Letters Week Of 8/23/2020: Sterility Assurance Failures
Warning Letters Week of 08/09/20: Unapproved HTC/P
Enforcement Spotlight: Retests Prove Key Data Integrity Concern
Warning Letters 07/26/20: Testing into Compliance
Warning Letters Week of 07/19/20: Unapproved New Devices
Warning Letters Week of 07/05/20: Supplier Qualification
Warning Letters 06/28/20: Unapproved Vendors
FDA Warning Letters Week of 06/21/20: For-Cause Inspection & Untitled Letter From A 2018 Inspection
Warning Letters Week of 06/14/20: Data Integrity
FDA Warning Letters Week of 05/24/20: Sterile Drugs, OTC Products, & Hiring of Quality Consultants
Warning Letters Week of 5/17/20
FDA Warning Letters Week of 5/10/20: 2 Untitled Letters from CBER, 2 to Implant Manufacturers
Warning Letters Week of 5/3/2020: 42 Concern COVID-19 Claims
FDA Emergency Use Authorizations for 2 Therapeutic Drugs
FDA Warning Letters Week of 4/27/2020: HCT/P
Roundup of Q1 2020 Food and Dietary Supplement Warning Letters
Warning Letters Week of 4/20/2020: Untitled Letter to Stem Cell Firm
Warning Letters Week of 4/13/2020: Compounding Pharmacy
FDA Warning Letters Week of 4/6/2020: Devices, BIMO
FDA Warning Letters Week of 3/30/2020: Pharma, Device, GLP, and Compounding Pharmacy
FDA Warning Letters Week of 3/22/2020: OTC and HCT/P
EMA Announcements Regarding Nitrosamine and MDRs
COVID-19 Briefing: Covington & Burling Teleconference
FDA Warning Letters Week of 3/8/2020: BIMO and OTC Products
Warning Letters Week of 3/1/2020: Device Design Controls
FDA Warning Letters Week of 2/23/2020: After 3-Week Absence, 8 to Drug and Device Firms
The Importance of Monitoring Import Alerts