- When a recall is issued, does FDA require the manufacturer to stop the manufacturing facility from continuing production of the product?
- No. A recall is specific to a product that is exhibiting a problem. FDA evaluates the data that comes in when the manufacturer does a recall. The manufacturer conducts an investigation to determine a root cause. FDA evaluates that data. If FDA deems that the problem may extend to other lots or products, FDA may originate an assignment and conduct an inspection. If as a result of the inspection, the problem is extended to other products, FDA would then have to extend the recall to other products.
- Are Notices of Inspection issued for domestic and foreign companies? Is there a database of performed inspections?
- Yes. The Compliance Status Information System (COMSTAT) is an FDA computerized redacted data system that contains the compliance status information on approximately 30,000 domestic and foreign drug, medical device and biologics manufacturers, repackers, assemblers, contract sterilizers and control testing laboratories. COMSTAT is a profile class and not a product specific system. FDA's Office of Regulatory Affairs maintains the user accounts that can be made available to federal, state and foreign regulatory agencies for accessing COMSTAT. For more information or to request a user account, an email may be sent to ForeignCOMSTATAccess@FDA.HHS.GOV
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Topic: page 7 of 8 (Lesson: page 33 of 35)