The US Department of Health and Human Services’ Office of Inspector General (OIG) asserted in a new report that the US Food and Drug Administration’s (FDA) practice of preannouncing foreign inspections, inadequate documentation of investigator training and its slow pace at issuing warning compromise the agency’s foreign inspections program.
However, the OIG found that the agency improved in some areas after implementing programmatic changes in 2017, such as its facility evaluation and inspection concept of operations (ConOps) program.
OIG decided to audit FDA’s foreign inspections program amid concerns that its oversight responsibility “has become increasingly complicated” as drugs are increasingly being manufactured outside the US. FDA reports that 74% of active pharmaceutical ingredient (API) manufacturers and 54% of finished goods manufacturers are located at foreign sites.
OIG reviewed 132 foreign for-cause drug inspections conducted from January 2016 through March 2017 and between January 2018 through March 2019. OIG also reviewed the training records of the 65 lead investigators who conducted these inspections.
The report was released against a backdrop of mounting frustrations with FDA’s foreign drug inspections program. Last July, legislators expressed concerns on the inspections backlog in a letter to Janet Woodcock FDA’s former acting commissioner and asked when FDA would be resuming its standard operations for foreign inspections.
This February, the Government Accountability Office (GAO) also issued a report recommending an overhaul of FDA’s foreign inspection program.
Exceeded six-month period for warning letters
OIG said FDA failed to meet its goal of issuing warning letters within six months of an inspection. FDA conducted nine foreign for-cause drug inspections that resulted in warning letters, yet three of the nine warning letters, or 33%, were issued more than six months after the inspection ended.
In one case, a warning letter was issued nine months after the inspection. During this lag, buyers and consumers were unaware of the violations while the drugs from the facility continued to supply the US market.
Unsubstantiated training of inspectors
Another problem was FDA’s failure to provide evidence of inspector training. For example, FDA could not substantiate that six of 65 lead investigators completed the necessary training. FDA said five were deemed experienced investigators but could not provide evidence to support this claim. For the sixth investigator, FDA stated that the investigator qualified as a Generic Drug User Fee Amendments (GDUFA) investigator, yet the investigator “was not included on the listing of GDUFA investigators that FDA provided to us.”
FDA attributed this failure to the fact that since 2002, hardcopy records were moved several times, and changes were made in its electronic training systems, resulting in the misplacement of certain records.
Announced inspections for violative firms
Another failing was FDA’s pre-announcing foreign for cause inspections at facilities with a history of GMP violations, instead of making surprise visits. This occurred 59% of the time even though the agency is not required to preannounce inspections. “If FDA announces all inspections, a facility could prepare for that inspection by correcting or concealing deficiencies or destroying records prior to the inspections,” said OIG.
According to OIG, FDA concurred with the report’s recommendations, and said it is working “to improve the timeliness of the overall foreign for-cause inspection process.”
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