Manufacturing Quality Issues in Healthcare and Cosmetics: An Analysis of FDA Surveillance Data.

Abstract

Background: Poor manufacturing quality in healthcare and cosmetic products expose people to danger and needs further categorization and assessment.

Objective: This study reviewed Food and Drug Administration (FDA) records to identify major types of quality issues, the type of products involved, and patterns occurring over time.

Methods: The "FDA Health Fraud Product" and "FDA Recalls, Market Withdrawals, and Safety Alerts" databases were assessed from June 4, 2010, through May 30, 2026. Drugs, cosmetics, and dietary supplements/quasi-legal products with verified manufacturing quality issues were included. Products were sorted by product type and FDA warning letters or official reports were reviewed and categorized.

Results: Of 266 reviewed entries, 195 manufacturing quality issues were elucidated from 184 unique products. Drugs accounted for 70% of issues, cosmetics for 21%, and dietary supplement/quasi-legal products for 9%, respectively. Overall, chemical contamination (30%), procedural or testing issues (29%), and microbial contamination (19%) comprised 78% of identified issues. Drug issues were primarily procedural/testing, chemical contamination, and microbial contamination; cosmetic issues were predominantly elemental impurities and chemical contamination; and dietary supplement/quasi-legal issues were mainly microbial contamination, procedural/testing, and elemental impurities. Particulate contamination occurred only in drugs. The number of issues per year showed no consistent trend, but spiked in 2020, 2022, 2024, and 2025.

Conclusion and relevance: Manufacturing quality problems varied substantially by product category and occurred in irregular clusters. Inconsistent FDA reporting practices and fluctuations in agency surveillance may have contributed to these patterns. Budgetary cuts to the FDA could increase consumer exposure to manufacturing issues.