FDA Reports on the State of Pharmaceutical Quality

FDA’s Center for Drug Evaluation and Research (CDER) recently released its fifth annual report on the State of Pharmaceutical Quality. It reviews the state of quality across FDA-registered drug manufacturers and drugs, including biological products, regulated by CDER.  The report also analyzes and identifies key quality elements of pharmaceutical manufacturers and their products. 

This report supports FDA’s vision to be the global benchmark of pharmaceutical quality surveillance and aims to inform stakeholders about the quality of the U.S. drug supply.

Additionally, the report highlights three (3) key initiatives that employ state-of-the-art approaches to oversee, characterize and achieve quality: 

  • Modernizing FDA’s Inspection Program
  • Quality Management Maturity (QMM) program
  • Supply Chain Reporting Requirement

This report provides a comprehensive picture of the state of pharmaceutical quality to support the FDA’s and consumers’ expectations for safe, effective, and high-quality medicines.


There are over 4,800 manufacturing sites in CDER’s Site Catalog with over 40% in the U.S.  India, China, Germany, and Canada round out the top 5 sites in the catalog.

CDER’s Drug Product Catalog includes over 140,000 application and non-application (non-FDA approved) products. Of the 227 named drug and biological ‘Essential Medicines’, 168 fall under CDER’s purview…the majority of whose manufacturing sites are located outside of the U.S.  The analysis for this report is based on sites, as the manufacturing volumes are currently unknown.  CDER expects drug amount reporting to be available in the future under the new supply chain reporting provisions of the CARES Act.

Field Actions by the Numbers

Process Quality Defects (PQD’s)

FDA receives, assesses and monitors post-market quality reports.  The COVID-19 public health emergency has had a significant impact on the number of Field Alert Reports (FAR) received.  As the demand for injectable products rose and fell during the public health emergency so did the number of FARs submitted.

Import Alerts, Recalls, and Warning Letters

During FY 2022, FDA issued 28 import alerts to sites for reasons related to drug quality.  The majority were delivered to sites who refused to respond to record requests and those with CGMP deficiencies that were identified through record review.  China and South Korea accounted for most of the alerts although they represented less than 15% of the foreign sites in the catalog. Unsurprisingly (considering the continuous media coverage of this issue in 2022) 86% of the imports from those 2 countries were for hand sanitizer manufacturing sites.

In FY2022, 166 sites accounted for 912 recalls, the highest number of recalls in five years.  As in prior years, the largest defect group for recalls continued to be CGMP deficiencies, with Respiratory Tract Agents having the most recalls. 

There were 72 CGMP-related warning letters issued in FY2022 (up considerably from FY2021) to pharmaceutical manufacturing sites. Almost half of these warning letters were issued to hand sanitizer manufacturers.  The increase in the number of warning letters to domestic manufacturers was attributed to the increase in domestic inspections.

Sampling and Testing

FDA’s sampling and testing program uses risk-based analytics to target potentially noncompliant products and found 892 of 1,552 samples to be noncompliant.  Over 66% of the imports-based tests uncovered noncompliance.  Products related to the COVID-19 public health emergency (whether domestic or imported) accounted for approximately 15% noncompliant samples – all for hand sanitizer products.

Advancing the Commitment to Quality

FDA is actively seeking to advance a commitment to quality by engaging with the industry to encourage the transition of focus from compliance to quality through continual improvement.

To drive a more vigorous pharmaceutical quality perspective, FDA is developing and utilizing new tools:

Modernizing FDA’s Inspection Program

The prime objective of the New Inspection Protocol Project (NIPP) is to modernize FDA’s inspection program.  With the new enhancements, the FDA will be able to conduct end-to-end inspections within a single platform.  The new initiative seeks to integrate planning between inspection protocols, FDA Form 483, inspection reports and regulatory notes. NIPP’s data management and analytical capabilities are being improved with automated data pre-processing and advanced predictive tools.

Quality Management Maturity (QMM)

CDER has continued its development of a QMM program for sites to promote the availability of high-quality drugs. CDER is working with stakeholders to strengthen quality systems and promote supply chain resiliency. 

In 2022, CDER presented the benefits of a QMM program before the Pharmaceutical Science and Clinical Pharmacology (PSCP) Advisory Committee and received unanimous support for the establishment of a QMM program.

CDER’s proposed schema for a QMM program addresses five areas of concern:

  • Management commitment to quality
  • Business continuity
  • Technical excellence
  • Advanced pharmaceutical quality system
  • Employee engagement

To ensure that the new QMM program is successful, CDER will continue to engage with stakeholders including pharmaceutical manufacturers, purchasers, payors, healthcare providers, pharmacies, and patients/consumers. Several foundational basics are currently under consideration including eligibility criteria for participation, whether FDA or a third party will conduct assessments, and whether assessments will be remote, virtual, or use a hybrid approach.

The FDA-funded Center of Excellence in Regulatory Science and Innovation at the University of Maryland provided an economic analysis of the potential effects of quality ratings on the pharmaceutical industry. The study concluded that “quality ratings should incent manufacturers to invest in quality processes with an aim toward reducing drug shortages.”

Supply Chain Reporting Requirement

The CARES Act added section 510(j)(3) to the FD&C Act, establishing a new reporting requirement for FDA-registered manufacturers.  These organizations must now report annually the amount of each listed drug that was ‘manufactured, prepared, propagated, compounded, or processed for commercial distribution.’  This data will strengthen drug quality oversight.

FDA intends to use Supply Chain reporting to support drug quality surveillance to:

  • Approximate market share
  • Gain insights on vulnerabilities and dependencies in the drug supply chain. Amount data will be more informative than approximating manufacturing with site counts. This could identify gaps in domestic EM production and track progress toward domestic manufacturing.
  • Support responses to natural disasters, supply chain interruptions, and potential shortages by identifying alternative manufacturing sites.
  • Strengthen the Site Selection Model and better prioritize surveillance inspections by providing an improved proxy for exposure to drug products.
  • Normalize PQDs by the amount of each product manufactured for distribution. With these data, PQDs rates can be evaluated for impact and potential signals.

In Brief:

Quality, not compliance, continues to be the prime focus of the Center for Drug Evaluation and Research.  Compliance is the baseline, but it’s only one component of a quality product.  This report analyzes and identifies key quality components of pharmaceutical manufacturers and their products.  It also provides an overview of three initiatives that address issues identified that will assist CDER in reaching its goals. With these advances, FDA will improve inspections and quality assessments to enhance supply chain resilience, reduce drug shortages, bolster emergency response, and strengthen stakeholder engagement. Using these enhanced risk management tools, FDA can better prioritize quality surveillance resources to protect the public from noncompliant products and increase confidence in the supply and quality of marketed drugs.

To discuss how these FDA initiatives to improve the State of Pharmaceutical Quality impact your organization, please contact research@axendia.com to schedule an Analyst Inquiry.

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The opinions and analysis expressed in this post reflect the judgment of Axendia at the time of publication and are subject to change without notice. Information contained in this post is current as of publication date. Information cited is not warranted by Axendia but has been obtained through a valid research methodology. This post is not intended to endorse any company or product and should not be attributed as such.

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