FDA Issues Summary of Inspection Items Listed on 483 Reports Issued in FY2017

FDA posted the summary of inspectional observation items listed on 483 reports from FY 2017 (10/2016 to 9/2017). During an inspection, ORA investigators may observe conditions they deem to be objectionable. These observations, are listed on an FDA Form 483 when, in an investigator’s judgment, the observed conditions or practices indicate that an FDA-regulated product may be in violation of FDA’s requirements. "These spreadsheets are not a comprehensive listing of all inspectional observations but represent the area of regulation and the number of times it was cited as an observation on an FDA Form 483 during inspections conducted by FDA and its representatives."

According to the posting, there were 2662 483's issued during FY 2017, compared to 2196 in 2016.    While the top 5 are similar to those listed in 2016, and most issues involve pest control, sanitation, processing concerns, and building  structure issues, there is a new item which is the Failure to Develop a FSVP (Foreign Supplier Verification Program).  The FSVP is for controlling foreign suppliers when a company not operating under Preventive Controls is importing the food.

Sliced Apples Recalled After Supplier Issued Recall of Whole Apples for Potential Listeria

Two companies are recalling sliced apple products after their supplier, Jack Brown Produce recalled whole apples for Listeria.

https://www.fda.gov/Safety/Recalls/ucm590372.htm
Fresh Pak Inc. Recalls Lot Specific Sliced Apple Products Because of Possible Health Risk
For Immediate Release
December 22, 2017

Research - Listeria Spreading in A Food Processing Plant

If a food processing plant was completely free of Listeria contamination, how long would it for Listeria to gain a foothold in the plant, and by what mechanisms would it spread?  Friend of the program, Dr. Mark Berrang, shared some of his research in advance of a talk he plans to give here at Penn State this spring.

Starting with a brand new further-process chicken facility, he found that within 4 months, persistent strains of Listeria had established itself in the drains.  The  incoming meat was the primary source of Listeria.  These strains remained even through cleaning and sanitizing of the operations.  Once in the drains, Listeria could become easily aerosolized even from a intermittent 2 second spray of water.  Reducing the incoming Listeria load is a challenge, and mitigation steps such as UV light may help.

As part of the Food Science Seminar Series, Dr. Berrang will discuss his work on Listeria in food processing facilities on March 1, 2018 at 4 pm in Room 252 Food Science.  Please contact Dr. Jasna Kovac (jzk303@psu.edu) for more details.

Journal of Food Protection, Vol. 73, No. 2, 2010, Pages 286–291
Colonization of a Newly Constructed Commercial Chicken

French Dairy Company Expands International Recall of Baby Milk

French dairy conglomerate Lactalis is expanding it worldwide recall of baby milk which was initially posted earlier this month.  In France alone, over 30 babies have become infected with Salmonella after consuming Lactalis product.   While product has been shipped to approximately 30 countries worldwide, it is not clear if infants in other countries have become ill.  Product in the US is not affected.

This is one of those incidents that will become a case study for what not to do....as soon as they figure out how this got so out of control.

Washington Post
Link
Europe
Mass recall of French-made baby milk over salmonella fears

By Jeffrey Schaeffer and Angela Charlton | AP  

December 21 at 7:06 AM  

FDA to Begin Tightening Down on Homeopathic Drugs

The FDA announced that will be putting more effort into enforcing regulations on homeopathic drugs.  What are homeopathic drugs?  According to the Homeopathy Center, "Homeopathic medicines – known as “remedies” – are made from natural sources (e.g., plants, minerals), and are environmentally friendly and cruelty free.  The thought is that if a natural substance causes similar symptoms, then this can be diluted and given to the patient to cure the symptoms....'like cures like'.  The example they give is this...."if you peel an onion, your eyes burn, itch and water. You might also have a runny nose and begin to sneeze. If you had similar symptoms during a cold or allergy attack, such as a runny nose, watery eyes and sneezing, a homeopathic micro-dose of the remedy Allium cepa (red onion) would help your body heal itself."

The other key for homeopathy is dilution of the natural substance...the more diluted the substance, the more potent it can be as a remedy. 'The technique for making a homeopathic medicine involves repeated dilution of a specific substance until little of the original substance remains".

Homeopathy is different than "herbal medicine, Chinese medicine, or other types of natural medicines."

FDA plans to better "address situations where homeopathic treatments are being marketed for serious diseases and/or conditions but where the products have not been shown to offer clinical benefits. It also covers situations where products labeled as homeopathic contain potentially harmful ingredients or do not meet current good manufacturing practices."

FDA News Release
For Immediate Release
December 18, 2017
Summary

FDA is proposing a new, risk-based enforcement approach to homeopathic drug products that have the greatest potential to cause risk to patients.

Wineries Begin Seeing Surprise FDA Inspections as Part of FSMA

Many firms are seeing FDA inspections for the first time as the FSMA regulations are coming into effect, including wineries.  An article in Wine Business Magazine (December, 2017) indicates that a number of wineries are undergoing surprise FDA inspections.  For many, this may be a new experience.

From the article, "New registration and record keeping requirements for wineries under FSMA impose important changes. Wineries must now renew their FDA registration every two years.."  Wineries must also comply with GMP requirements, including the need to have documented employee training.  These firms are exempt from the the risk based preventive controls (Subpart C) and the supply chain program (Subpart G).

MA Firm Expands Recall of Smoked Fish Products After Further Testing

A Massachusetts firm is expanding its recall posted on December 13 after further testing of the environment and product.  According to the recall notice,  "The recall expansion was initiated as a result of environmental and product sampling conducted by the firm."   From this it seems that they did not have a good handle on Listeria in their environment, which for smoked seafood items, can be a real big deal.

FDA Recall Notice
https://www.fda.gov/Safety/Recalls/ucm589893.htm
Springfield Smoked Fish Expands their Recall of Smoked Salmon Because of Possible Health Risk
For Immediate Release
December 19, 2017

Produce Company Recalls Apples Due to Supplier's Positive Listeria Test Results

A Michigan produce company is recalling apples processed and shipped by one of its suppliers after  routine sampling program by that supplier revealed that finished products contained Listeria monocytogenes.

It seems that product was shipped prior to results coming back.  It is unknown whether the produce company was aware that the supplier had sampled product for testing.  It would seem that a test and hold procedure should have been in place.

FDA Recall Notice
https://www.fda.gov/Safety/Recalls/ucm589722.htm
Jack Brown Produce, Inc. Recalls Gala, Fuji, Honeycrisp and Golden Delicious Apples Due to Possible Health Risk
For Immediate Release
December 19, 2017

Rattlesnake Pills Source of Salmonella Infection

Rattlesnake pills have been linked to a case of salmonelloisis in Kansas.  The pills, which were purchased in Mexico, contain dehydrated / ground rattlesnake meat and are used to treat various conditions such as HIV and cancer.  I guess when you have one of these types of diseases, why not throw some rattlesnake at it.   Sounds good, but activity against disease is probably not validated and ground snake meat, if not properly treated, may contain Salmonella.

Infection Control Today
http://www.infectioncontroltoday.com/news/2017/12/investigation-of-a-salmonella-infection-linked-to-rattlesnake-pills.aspx
Investigation of a Salmonella Infection Linked to Rattlesnake Pills