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FDA Field Alert Reports Required for Anomalies That Occur During Distribution

May 8th, 2012

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FDA expects firms to submit field alert reports (FARs) for recurring technical defects discovered through the complaint process even when there is no evidence of the issues in site production records or retained samples.

At a Q&A session at the University of Georgia/FDA International GMP conference in March, Atlanta district Consumer Safety Officer (CSO) Penny McCarver explained that a complaint – for example, about broken tablets – may be an indication of a problem occurring during product distribution.

“Even though you don’t see anything in your retained samples and you don’t find anything in the batch record, you still need to submit the field alert and you need to investigate,” she emphasized.  “Just because it is not in your retained samples doesn’t mean that it didn’t happen out there in the field.”

However, she noted, there are some cases when a FAR does not need to be submitted for a quality defect – for example, a single broken tablet in a distributed bottle, provided the lot was produced within established quality limits and the breakage is not part of an adverse trend.

In turn, McCarver emphasized the need for firms to have a procedure in place identifying a “threshold” for filing a FAR, such as a minimum number of complaints for a broken tablet in a lot or bottle.  The SOP should also include provisions for looking at trends and determining when a trend will trigger filing a FAR.

At the UGA conference, Bonita Chester – a Level 3-certified member of the pharmaceutical inspectorate and resident-in-charge of the Atlanta District’s Greenville, South Carolina office – gave a presentation on the regulatory requirements for reporting field alerts and how the agency ensures compliance with those requirements.  She provided examples of the kinds of problems that are reportable and how they should be reported (see box below).

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