Enforcement

Breakdowns of enforcement actions, trends, and what they signal for regulated organizations.

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Alison Sathe
Anders Vinther
Barbara W. Unger
Jackie Torfin
Jerry Chapman
Jon Falker
Katie Terry
Mark Agostino
Rebecca Stauffer
Redica Systems
Roger Angarita
Sarah Boynton
Scott Sherrill
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Enforcement

Limiting Plant Access and Sharing Redacted Documents Results in Import Alert and Warning Letter

January 28, 2025
Jerry Chapman
FDA
import alert
Inspection
Tianjin Darentang Jingwanhong
Tianjin Darentang Jingwanhong Pharmaceutical
Enforcement

Granules India FDA 483 Includes Potential Contamination and Data Integrity Findings

November 26, 2024
Jerry Chapman
483
483 Findings
Data Integrity
Form 483
Granules India
Enforcement

Navigating FDA Guidelines for Combination Products: A Comprehensive Guide

November 6, 2024
Redica Systems
Combination Products
FDA Database
FDA Approval
Guidelines
medical devices
Enforcement

ICH Q9 Quality Risk Management in Pharma

October 15, 2024
Redica Systems
ICH
ICH Q9
Pharma
QRM
Quality Risk Management
Enforcement

FDA Inspection Shows Systemic Data Falsification Issues

October 11, 2024
Jerry Chapman
483
API
API Manufacturer
Data Falsification
Enforcement

Comprehensive Guide to 21 CFR 820.30 for MedTech

October 8, 2024
Redica Systems
483 observations
ALCOA
consent decree
EMA
FDA
Enforcement

Homeopathic Product for Infants Contaminated with Bacteria and Cancer-Causing Lubricant

July 23, 2024
Jerry Chapman
contract manufacturing
drug product recall
Form 483
Inspection Issues
quality system labeling
Enforcement

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

July 18, 2023
Jerry Chapman
FDA
Internal Audits
Pharma
Supplier audits
Swissmedic
Enforcement

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

July 13, 2023
Jerry Chapman
China
Clinical Trial Guidance
Enforcement

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

July 12, 2023
Jerry Chapman
CDER
FDA
MAPP
Pharma
Policy
Enforcement

Expert Commentary: FY2022 Report on the State of Pharmaceutical Quality

June 29, 2023
Redica Systems
483
FDA
GMP
Report
Warning Letter
Enforcement

Internal Audit Reports: Can the FDA Take a Peek?

April 19, 2023
Jerry Chapman
FDA
GMP
Internal Audits
Pharma
Quality
Enforcement

FDA Issues 38-Page 483 to Solid Oral Dosage Manufacturer

February 23, 2021
Redica Systems
No items found.
Enforcement

OTC Skincare Firm Receives Warning Letter Due to CGMP Concerns

January 13, 2021
Redica Systems
No items found.
Enforcement

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

December 8, 2020
Redica Systems
No items found.
Enforcement

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

November 17, 2020
Redica Systems
No items found.
Enforcement

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

November 10, 2020
Redica Systems
No items found.
Enforcement

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

November 3, 2020
Redica Systems
No items found.

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