FDA Office of Compliance - Annual Report FY 2023 Published

The Office of Compliance's Fiscal Year (FY) 2023 Annual Report published a detailed overview of various initiatives, primarily focused on inspections, quality, and Good Manufacturing Practice (GMP) compliance. The Director's Message at the beginning of the report highlights the commitment to public health safety. This includes a concerted effort to prevent the contamination of medicines, in particular by diethylene glycol and ethylene glycol, and to ensure the safety of ophthalmic medicines. Tackling drug shortages and the risk of contamination is an important area of focus.

A key aspect of the report is the protection of the national drug supply against contamination

The activites involve vigilant monitoring of medicines, particularly over-the-counter (OTC) medicines, for signs of microbial and other types of contamination. The response includes extensive testing, inspections, and the issuance of Warning Letters and recalls for products found to be significantly contaminated. Implementation of the Drug Quality and Security Act (DQSA) is another critical area. The Act's provisions relate to the compounding of human medicines and securing the drug supply chain against illicit products. Measures for this are developing policies, conducting inspections and taking regulatory action to ensure the safety and quality of compounded drugs.

Compliance in drug manufacturing is strongly emphasised in the report

It details outreach activities, including webinars and conferences, which focus on discussing drug manufacturing quality systems and CGMP requirements. Compliance actions against non-compliant manufacturers are also significant, including injunctions and Warning Letters, with common CGMP violations involving quality control and testing controls.

The following metrics provide a snapshot of drug manufacturing facility compliance actions. Visit FDA's Data Dashboard - Home for more information.

Interesting is also the basis for Warning Letters with CGMP or adulteration citations in 2023. The majority of drug CGMP or adulteration Warning Letters were issued after an on-site inspection, either a facility's first inspection or a reinspection. In FY23, the FDA issued 28 percent of the CGMP Warning Letters while utilizing FDA's remote oversight tools.

Ensuring the accuracy and integrity of drug registration and listing data is another area of focus. The report mentions the inactivation of drug listings for non-compliance and the issuance of Warning Letters to companies for inaccurate or incomplete data. The report classifies 264 recall events, mainly due to CGMP deviations, lack of sterility assurance and failure to meet impurity specifications. Inspections are therefore conducted to ensure compliance with regulatory standards and Warning Letters are issued for non-compliance. Following the DEG poisoning incidents, there is an increased focus on ensuring the safety and quality of liquid dosage forms. This includes close scrutiny of these drugs and the issuance of manufacturing guidelines to prevent EDC contamination.

The report also discusses work to implement the Drug Supply Chain Security Act (DSCSA). It focuses on improving the security of the distribution of medicines, including finalising guidance documents and monitoring industry readiness.

More than 600 inspections and regulatory assessments were conducted, including more than 400 to assess the reliability of data for marketing applications

The summaries of these inspections are used to support the review of marketing applications. Efforts are underway at FDA to refine processes and improve co-ordination between offices.

Finally, the appendices provide details of the organisational structure, including the various offices such as Compounding Quality and Compliance, Drug Security Integrity and Response, and Manufacturing Quality. They also list compliance-related guidance issued in FY23, covering areas such as DSCSA implementation, human drug compounding and manufacturing compliance.