Enforcement Posts

Blog

Internal Audit Reports: Can the FDA Take a Peek? Part 2: Other Agencies

Jerry Chapman
Blog

Expert Commentary | China Updates Clinical Trial Guidance on “Safety Information Assessment and Risk Management Work Procedures”

Jerry Chapman
Blog

Expert Commentary | Updates to FDA’s Manual of Policies and Procedures (MAPP)

Jerry Chapman
Blog

Expert Commentary: FY2022 Report on the State of Pharmaceutical Quality

Jerry Chapman
Blog

Internal Audit Reports: Can the FDA Take a Peek?

Jerry Chapman
Blog

FDA Issues 38-Page 483 to Solid Oral Dosage Manufacturer

Barbara W. Unger
Blog

OTC Skincare Firm Receives Warning Letter Due to CGMP Concerns

Redica Systems
Blog

FDA Warning Letters: 11/22/2020 & 12/1/2020

Barbara W. Unger
Enforcement

FDA Warning Letters Week Of 11/8/2020: Process Validation Failures

Barbara W. Unger
Enforcement

Warning Letters Week Of 11/1/2020: Hold Times

Barbara W. Unger
Enforcement

Warning Letters Week Of 10/25/2020: Cleaning Validation

Barbara W. Unger
Enforcement

Warning Letters Week Of 10/18/2020: Misbranded Biologics

Barbara W. Unger
Enforcement

Warning Letters Week Of 10/11/2020: Unauthorized Cell Therapy

Barbara W. Unger
Blog

Warning Letters 10/4/2020: Medical Device Adverse Events

Barbara W. Unger
Blog

Q2 2020 Food and Dietary Supplement Warning Letters

Patty Harvey
Enforcement

Warning Letters Week Of 9/27/2020: Aseptic Process Issues

Barbara W. Unger
Enforcement

Warning Letters Week Of 9/20/2020: Quality Unit Failures

Barbara W. Unger
Blog

Warning Letters Week Of 9/13/2020: Lack of Validation

Barbara W. Unger
Blog

Highlights from Recent FDA Inspections of Vendors/Suppliers

Rebecca Stauffer
Blog

Warning Letters Week Of 9/6/2020: Data Integrity Failures

Barbara W. Unger
Blog

Warning Letters Week of 8/30/2020: Adulterated Products

Barbara W. Unger
Blog

Warning Letters Week Of 8/23/2020: Sterility Assurance Failures

Barbara W. Unger
Enforcement

Warning Letters Week of 08/09/20: Unapproved HTC/P

Barbara W. Unger
Blog

Enforcement Spotlight: Retests Prove Key Data Integrity Concern

Rebecca Stauffer
Blog

Warning Letters 07/26/20: Testing into Compliance

Barbara W. Unger
Blog

Warning Letters Week of 07/19/20: Unapproved New Devices

Barbara W. Unger
Blog

Warning Letters Week of 07/05/20: Supplier Qualification

Barbara W. Unger
Blog

Warning Letters 06/28/20: Unapproved Vendors

Barbara W. Unger
Blog

FDA Warning Letters Week of 06/21/20: For-Cause Inspection & Untitled Letter From A 2018 Inspection

Barbara W. Unger
Blog

Warning Letters Week of 06/14/20: Data Integrity

Barbara W. Unger
Blog

FDA Warning Letters Week of 05/24/20: Sterile Drugs, OTC Products, & Hiring of Quality Consultants

Barbara W. Unger
Blog

Warning Letters Week of 5/17/20

Barbara W. Unger
Enforcement

FDA Warning Letters Week of 5/10/20: 2 Untitled Letters from CBER, 2 to Implant Manufacturers

Barbara W. Unger
Blog

Warning Letters Week of 5/3/2020: 42 Concern COVID-19 Claims

Barbara W. Unger
Enforcement

FDA Emergency Use Authorizations for 2 Therapeutic Drugs

Barbara W. Unger
Blog

FDA Warning Letters Week of 4/27/2020: HCT/P

Barbara W. Unger
Blog

Roundup of Q1 2020 Food and Dietary Supplement Warning Letters

Patty Harvey
Blog

Warning Letters Week of 4/20/2020: Untitled Letter to Stem Cell Firm

Barbara W. Unger
Enforcement

Warning Letters Week of 4/13/2020: Compounding Pharmacy

Barbara W. Unger
Blog

FDA Warning Letters Week of 4/6/2020: Devices, BIMO

Barbara W. Unger
Blog

FDA Warning Letters Week of 3/30/2020: Pharma, Device, GLP, and Compounding Pharmacy

Barbara W. Unger
Blog

FDA Warning Letters Week of 3/22/2020: OTC and HCT/P

Barbara W. Unger
Blog

EMA Announcements Regarding Nitrosamine and MDRs

Barbara W. Unger
Blog

COVID-19 Briefing: Covington & Burling Teleconference

Marlene Bobka
Enforcement

FDA Warning Letters Week of 3/8/2020: BIMO and OTC Products

Barbara W. Unger
Blog

Warning Letters Week of 3/1/2020: Device Design Controls

Barbara W. Unger
Blog

FDA Warning Letters Week of 2/23/2020: After 3-Week Absence, 8 to Drug and Device Firms

Barbara W. Unger
Blog

The Importance of Monitoring Import Alerts

Barbara W. Unger