1. Office of Inspector General. The Food and Drug Administration’s foreign for-cause drug inspection program can be improved to protect the nation’s drug supply. Accessed December 18, 2023. https://oig.hhs.gov/oas/reports/region1/11901500.asp
2. United States Government Accountability Office. FDA should take additional steps to improve its foreign inspection program. Accessed December 18, 2023. https://www.gao.gov/assets/gao-22-103611.pdf
3. Oestreich L, Giaquinto M, Auchincloss K. Trends in FDA FY2022 inspection-based warning letters. Accessed December 18, 2023. https://www.outsourcedpharma.com/doc/trends-in-fda-fy-inspection-based-warning-letters-0001
4. OMUFA II Ratifiers Steering Committee Meeting. OMUFA reauthorization: introductory public meeting. Accessed December 18, 2023. https://www.fda.gov/media/172798/download
5. U.S. Food and Drug Administration. OTC warning letters. Accessed December 18, 2023. https://www.fda.gov/drugs/enforcement-activities-fda/otc-warning-letters#ophthalmics