FDA suspends most on site inspections because of COVID-19 concerns
In a statement that accompanied the webcast, FDA Commissioner Dr Stephen Hahn MD, said the agency had already put work from home mandates in place, and this new directive is an extension of that.
“While this does not apply to those carrying out non-portable activities, such as certain lab activities or the monitoring of imported products, we will continue to adjust our approach to a number of activities, including facility inspections for all FDA-regulated products such as food, animal feed, drugs, biological products, devices and tobacco,” Hahn said.
“We must ensure our workforce remains healthy to carry out the FDA’s critical public health mission to keep Americans safe,” Hahn said in the statement.
The scaling back of inspections domestically follows on FDA’s earlier suspension of inspections of facilities in China.
Hahn said inspections of imported products will continue, but for the moment domestic facility inspections are suspended. The agency will seek other ways, including document review, to perform some of the functions that would otherwise have taken place in a physical audit.
Document review can give good snapshot of compliance
Larisa Pavlick, head of regulatory and compliance for the United Natural Products Alliance, said inspectors still could be effective even without a physical audit. Pavlick has first hand experience from her years as an FDA inspector working out of the Denver office.
“You could still request and look at records for raw materials. They’re supposed to have two people working on raw material intake, one doing the verifying and the other doing the weighing,” she said.
“You could look at critical points in the manufacture to see if theoretical weights match actual rates. You can compare master manufacturing records to batch records,” Pavlick added.
Pavlick said one of her strategies as an inspector would be to request logs pertaining to the manufacture of a certain product over time to get a feel for how a company conducts its business. If a blender was cleaned properly for a certain batch, is the same cleaning record there for the same product when it was manufactured a year previously? That kind of review is still possible under the new guidelines, she said.
Loosened FSMA requirements
In a press release about the webinar the American Herbal Products Association noted that in addition to keeping its own inspectors at home, the agency was waiving the requirement for manufacturers to do on site audits of their suppliers as mandated under the Food Safety Modernization Act.
Pavlick said here, too, a great deal of important information can be gleaned from documentation.
“If for example there were a kill step called for to deal with microbial contamination, you look at time and temperature logs. You could also look at the logs for the thermometers to see if they were calibrated and when they were calibrated,” she said.
“Some suppliers might control things with pH, so you could look at the pH logs to see if things were in the proper range,” Pavlick added.
Positive note on compliance
Hahn sounded a positive note about industry compliance in his statement, reassuring consumers that the products on the shelves will still be safe.
“From our experience across the agency, we also believe FDA-regulated firms understand and appreciate their shared responsibility to ensure the integrity of the supply chain and we will continue to communicate with them during this time to underscore this partnership,” he said.