FDA Records Reveal Lapses in Drug Safety Checks: Analysis

FDA inspection records show that some generic drug manufacturers are routinely failing to carry out basic safety and quality checks, raising concerns about the integrity of medications reaching U.S. patients, according to a new report published March 30 by the MedShadow Foundation. The analysis, authored by Emma Yasinski, found that some companies are not adequately testing ingredients, reviewing manufacturing records, or following established quality control procedures — core requirements intended to ensure drug safety and quality.

Between 2014 and 2025, FDA inspectors cited two closely related regulatory violations more than 3,200 times:

• 21 CFR 211.22(d): Failure to establish and follow adequate quality control procedures
• 21 CFR 211.192: Failure to thoroughly review manufacturing records and investigate discrepancies

Both violations signal breakdowns in quality assurance systems, former FDA inspector Peter Baker told the group. In practical terms, these lapses can mean manufacturers are not confirming the identity or purity of ingredients, not reviewing whether production processes performed as expected, or failing to investigate anomalies before releasing products to market. “When quality assurance is missed, contaminated or substandard drugs can reach pharmacies and hospitals,” the report noted, with potential harms only becoming apparent after patients are exposed.

The report also identified three other frequently cited violations:

• Failure to establish proper production and process controls (21 CFR 211.100(a))
• Failure to implement scientifically sound testing and quality standards (21 CFR 211.160(b))
• Failure to prevent microbial contamination in sterile products (21 CFR 211.113(b))

Collectively, these deficiencies point to gaps in manufacturers’ ability to ensure drugs meet required standards for identity, strength, quality, and purity.

The findings have prompted renewed scrutiny of the industry’s reliance on internal quality systems. The report suggested that self-policing by manufacturers may leave critical vulnerabilities unaddressed. As a potential remedy, the analysis highlighted proposals for independent batch testing by third parties, such as academic or government laboratories, before drugs are released to consumers.

The report concluded that while regulatory frameworks are in place, persistent violations indicate that enforcement and oversight mechanisms may need to be strengthened to better safeguard the drug supply.