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EXPERT: COMPANIES CAN EXPECT MORE GOVERNMENT OVERSIGHT IN WAKE OF NATURAL DISASTERS
Jun. 8, 2011
Source: FDAImports news release
Companies that are directly affected by a major natural disaster or weather event, such as the Joplin, Missouri tornadoes or the earthquake and tsunami in Japan, should expect a heightened level of federal and state oversight in the future especially when it comes to facilities, documentation and equipment. Benjamin L. England, founder and CEO of FDAImports.com, LLC, summarizes these FDA concerns here:
1. Facilities: Facility integrity will be a major factor in assessments including warehousing, manufacturing plants and other structures related to the import/export process. Exporters must know precisely the extent of any immediate facility damage as well as think through longer term facility issues in the region.
2. Documentation: Federal and State inspectors will be pursuing documentation that perishable food, frozen food or drug products and components either stored or in process at the time of the event (or shortly thereafter, given power disruptions) were held at proper temperatures throughout. Manufacturers will need to be prepared to meet the documentation demands even in the midst of serious workflow disruption.
3. Equipment: Numerous quality control issues arise for operations that must maintain tight equipment specifications or that are validated to ensure a certain food, drug or medical device manufacturing outcome. For example, a low acid canned food manufacturer whose aseptic processing unit on one line now has a breach in its pressure chambers; or a sterile injectable drug/vial filling machine that was disrupted resulting in improper insertion of the vial stopper.
Companies outside of an impact area might also be indirectly affected by a natural disaster, extreme weather event, flood or state of emergency. Numerous factors can hinder or halt production, export or delivery, even for companies thousands of miles away. Supporting suppliers may be in the damage path, have had power disruptions or suffered facility, storage, equipment or packaging material integrity problems due to violent weather (tornadoes or earthquakes). Supply line routes and supporting transportation infrastructure can also be disrupted. Overall, a natural disaster or weather-related event creates a bottleneck of obstacles for manufacturers, suppliers, distributors and import/export companies in addition to the personal and economic devastation.
Benjamin L. England is a former 17-year veteran of the FDA and served as the Regulatory Counsel to the Associate Commissioner for Regulatory Affairs. Currently he is founder and CEO of FDAImports.com, LLC, a firm of consultants and affiliated attorneys practicing at the intersections of complex administrative law and regulations that impact international traders in highly regulated commodities.
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