FDA’s Foreign GMP Audits Are Inadequate, Reports GAO
[Thursday, December 12, 2019]
The GAO reports this week that FDA is severely short of inspectors capable of auditing foreign sites, it gives up to 12 weeks’ notice to foreign sites prior to inspections giving them ample opportunity to clean-up and cover deficiencies, and its inspectors for foreign sites are given inadequate time to complete their job making them cut corners. The report is a scathing critique of FDA’s auditing program particularly for foreign manufacturing sites. According to GAO, FDA has made several improvements since 2012 when another GAO report at that time listed several deficiencies on the same topic, however, there are still several concerns about FDA’s ability to assure quality of imported drugs. FDA officials have insisted that adequate measures exist to assure quality of drugs imported into the country, but the GAO report lists several major concerns about the adequacy of FDA’s foreign inspection practices. About 40% of foreign inspections conducted by FDA are in India and China. About 70% of these inspections were surveillance inspections, i.e., inspections of sites exporting drug products currently marketed in the US. FDA inspections of manufacturing sites in India and China identified deficiencies in 64% of the audits, but only about 8% of the deficiencies were serious enough to garner the OAI designation. OAI or Official Actions Indicated is the most serious designation requiring sites to address major issues and often lead to Warning Letters and Import Alerts if not addressed quickly. About 92% of the identified deficiencies were classified as VAI, or Voluntary Actions Indicated, meaning these could be addressed voluntarily by the manufactures and would not affect the export of drugs manufactured at those sites to the US. The biggest problem for FDA is failure to recruit enough inspectors for foreign sites. Inspectors based in the US need to plan their trips in advance and are unable to conduct unannounced or short-notice inspections hence end up giving as much as 12 weeks’ notice to the target sites giving them time to clean-up and cover-up. FDA’s inspectors based in India and China can conduct unannounced visits but there is a severe shortage of staff at FDA’s offices in India and China due to several logistical challenges. For example, it takes up to 2 years to place a new inspector in India and China by which time the posted inspectors may have changed their mind about accepting the foreign posting. Then there are issues such as lack of translators, lack of scheduling flexibility, and lack of sufficient time to conduct an audit and write reports makes FDA’s foreign inspections lacking in many ways. The GAO report details many aspects of FDA inspection processes, both domestic and foreign, that should be useful background for all manufacturing sites.