Saturday 19 May 2012

FDAUpdate

Notes from RAPS Breakfast with Atlanta District Director John Gridley

I attended the Atlanta RAPS FDA update breakfast today. The guest speakers were district director John Gridely and director of compliance Phil Campbell.

Here are my notes on the comments made by Director Gridely.

Although we were in a room with only a couple of food focused practitioners, the Director’s comments all fell on FSMA.

  • FSMA is pushing for more work with states, mostly department of agriculture so that state inspections mirror FDA. This includes most state inspectors attending the same training as FDA inspectors.
  • The director described this as a “more coordinated effort” often with states conducting a component inspection.
  • On the anniversary of FSMA the FDA will issue 3 or 4 new rules, one of them likely to address dietary supplements (an area the Director said is gaining increased scrutiny).
  • Retail standards will be coming out under FSMA in the New Year.
  • Foreign inspections are a growing area of concern along with imports. The Director noted foreign inspection went from 200 in 2010 to 1000 in 2011. He also noted the FDA is on track to conduct 1200 in 2012 and 2400 in 2013 (as required by FSMA); the budget for those inspections is in place.
  • If a foreign facility refuses an inspection then the FDA will exercise its authority under FSMA to place an auto stop (a refusal) on incoming goods.
  • Also, foreign facilities that are slow with inspections or have problems will have 100% of imported items inspected. The Director was firm when he said 100% for ‘high risk’ firms. This will be a major slow down for non-compliance firms.
  • What the FDA is doing with FSMA will be mirrored with medical device and pharma – third party certification, more foreign inspection, import controls.
  • The FDA is evaluating what it means to be third party certification – there is a concern that it will be misused as a rubber stamp for auditors with ties to the firm inspected.
The Director of Compliance made several points most important about PREDICT the risk-based screening system for imports. There will no longer be manual review of imports if its not in the electronic database (the item and facility both are registered) it will be refused.
The PREDICT system is highly sophisticated it will look at the country of origin, product, brokers etc to analyze risk. The example the Compliance Director gave was honey passed to Korea, relabeled and shipped to the US. That honey will be rejected under PREDICT because it can estimate Korea’s honey production and look for trends of product imports that exceed its production capacity. Fed Ex has challenged the use of PREDICT and lost. The Commissioner made clear to all district offices that PREDICT is in place and no manual reviews.
The Director of Compliance also provided a list of the top 10 citations for medical device and pharama in 2011. To receive that list please write to msanchez@curiouslaw.com.

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