FDA Inspection Report Slams Novartis Inaction

“As of 12/12/11, your firm is overdue (untimely) with adequately conducting approximately 1,360 investigations you have received from consumer complaints (1332 are major, 31 are critical). This backlog of overdue complaints has been over 1,000 in number since at least 8/30/11.”

– FDA to Novartis Consumer Health (Lincoln, Nebraska), January 20, 2012

FDA has just released (January 30, 2012) a scathing 23-page Inspectional Observations (Form 483) report, which the agency issued to Novartis Consumer Health ten days ago, following completion of a reinspection of the company’s Lincoln, Nebraska facility.

The inspection report details numerous examples of egregious and unconscionable disregard for consumer safety on the part of Novartis Consumer Health – many of them issues that remain unaddressed since the facility was inspected last July. Consumer complaints of product mix-ups and chipped tablets have either not been investigated, or the investigation was inadequate, incomplete or delayed.

Some of the most flagrant deficiencies highlighted in the latest FDA report include:

As of 12/21/11, your firm … has approximately 360 consumer returned complaint samples of various products (major and critical complaints) that have not been thoroughly reviewed by your Quality Unit. … [The problems] requiring investigation include, but are not limited to: foreign product, foreign object, suspected tampering, chipped/cracked/crumbled tablets, broken/missing seal, etc. … Your firm is outside of procedural timeframes for completing approximately 340 open Corrective and Preventative Action requirements … and 48 deviation … investigations.

[I]nvestigation fails to address how “28 assorted tablets” (some not packaged in the room, such as Gas X, Soft Gels, etc) could have entered a room dedicated to packaging other products.

[I]nvestigation, opened 11/18/11 and closed 12/16/11, into a complaint for “12 extra tablets”, found by a pharmacist after opening a sealed bottle of Morphine Sulfate ER 30mg… is deficient. … This is important because this consumer complaint was recently closed and is indicative of how your firm is currently investigating consumer complaints.

Your most recent consumer complaint (opened 12/16/12 and closed 12/20/11) into Bufferin RS Tablets, Lot: 10095189, for partial/incomplete tablet caplets, dues not address all lots of product potentially affected by the problem of over-compressed tablets identified as the root cause. Your firm was aware of Partial/Incomplete Bufferin tablets/caplets issues since at least 2009, yet a Medical safety Assessment Report was not released until 10/14/11. There is no justification or explanation for the approximate 2 year delay in obtaining this report.

There is not root cause identified for the foreign tablets potentially in a Prevacid 15 MG Capsule container. … You have had 35 mixed tablet/foreign products for Prevacid 15 mg Capsules since 2009.

It is important to understand because of your firm’s failure to adequately and thoroughly conduct investigations, it is difficult to determine how widespread the problems are at your firm…

Your packaging line clearance operators failed to adequately clean packaging lines (and areas around packaging lines) during your “major” cleaning efforts of this equipment…

Your most recent Annual Product Review (APR) for Bufferin Extra Strength Tablets and Bufferin Regular Strength Tablets (2010) is incorrect. …

Your most recent 2011 Annual Product Review for Excedrin Extra Strength Express Gels … approved 5/27/11, is deficient. The report fails to document the consistent trend of complaints received by your firm for “Product Chipped, Cracked, Crumbled” and “Partial/Incomplete Tablet/Caplets” regarding this product. … Your firm has been aware of “Product Chipped, Cracked, Crumbled” and “Partial/Incomplete Tablet/Caplets” for this product (Express Gels) since at least 2009, yet a complete market correction (due to this problem) was not executed until 1/8/12, which occurred during the course of this FDA inspection.

The conclusion in your most recently completed 2011 Annual Product Review for Benefiber Plus Calcium Powder, signed as acceptable on 6/27/11, is not supported by the information in the report.

You have failed to document the root cause, and implement effective corrective and preventative actions, regarding product mix-up complaints for solid dosage form foreign tablets of products manufactured at your firm since at least 2009. (Referring to products such as: Excedrin family products, Prevacid, narcotic products, etc… Your foreign product recall assessment, dated 10/17/11, states you have received approximately 70 confirmed, returned customer complaint, mix-up samples containing only NCH-Lincoln produced product. In total, There have been 400 complaint cases of this type since 2009.

There is an inadequate number of Quality Unit personnel in your firm to conduct timely, correct and thorough reviews of the products you manufacture.

And, repeated over and over again throughout the 23-page report, is the statement – highlighted BY THE FDA INSPECTOR in upper case and bold-face:

THIS IS A REPEAT VIOLATION FROM THE PREVIOUS INSPECTION AT YOUR FIRM DATED 6/13-7/8/11

I would not be surprised to see another recall announcement from Novartis Consumer Health – one that covers all products manufactured by the company since 2009 at its Lincoln, Nebraska production plant.

Profiling Campylobacter spp.

Roughly 90% of retail poultry in the USA harbors Campylobacter.

Some history

Campylobacter fetus – originally known as Vibrio fetus – was first associated with diarrheal illness in 1957. By the mid- to late-1980s, Campylobacter was recognized as one of the most common causes of diarrhea worldwide. The species that is most commonly linked to human illness is Campylobacter jejuni.

What is Campylobacter, and where is its natural habitat?

Campylobacter is a heat-loving bacterium, which grows best at 108ºF (or 42ºC), several degrees warmer than the temperature preferred by other pathogens such as E. coli, Shigella or Salmonella. It does not grow at cooler temperatures (below 86ºF), but can survive at refrigerator temperatures. The microbe typically looks like a rod that has been bent into a curve or twisted to form a spiral. Campylobacter lives in the intestinal tracts of birds and mammals around the world.

How is Campylobacter transmitted? What is the incubation period of the infection?

Campylobacter is most commonly transmitted when someone eats undercooked or contaminated poultry, drinks unpasteurized milk or contaminated water, or by hand-to-mouth contact with household pets (including backyard poultry) that carry the bacteria. The typical incubation period is 2 to 5 days.

What is campylobacteriosis? How long does it take to develop?

Campylobacter produces a form of gastroenteritis, much like Salmonella. The length of time required for symptoms to appear is usually two to five days, but will depend on the size of the infective dose and the susceptibility of the victim. It takes as few as 800 to as many as one million Campylobacter organisms to infect 10-50% of individuals.

**What are the symptoms of Campylobacter infections?**

Symptoms include diarrhea (sometimes bloody). fever and abdominal cramps. In most cases, the symptoms last from 2 to 10 days.

What is the prognosis of a Campylobacter infection?

Most Campylobacter infections are self-limiting, and symptoms disappear in 2 to 10 days. In less than 1% of cases, a patient can develop bacteremia (bloodstream infection). Occasionally (less than 1 case in every 1,000), individuals infected with Campylobacter develop Guillain-Barré syndrome – an autoimmune disease that affects the peripheral nervous system. Approximately 10% of Guillain-Barré cases are fatal.

**What foods carry Campylobacter?**

Most raw poultry purchased by consumers in the USA and Canada is contaminated with Campylobacter. Incidence rates are somewhat lower in many European countries, but still significantly higher than the incidence of Salmonella contamination. Raw (unpasteurized) milk also can a vehicle for Campylobacter, and consumption of unpasteurized dairy products is linked to small outbreaks of Campylobacter gastroenteritis a few times every year.

**How can people protect themselves from Campylobacter infections?**

Campylobacter is killed during pasteurization of milk and by normal cooking procedures. Ways to minimize the risk of contracting Campylobacter infections include:

Always cook poultry thoroughly, to an internal temperature of 165ºF (74ºC)
Take care to avoid contact between raw poultry juices and foods that are ready-to-eat, including cooked meats, side dishes, salads and desserts
Wash and sanitize hands, utensils and work surfaces after working with raw poultry
Avoid consuming raw milk and dairy products made using unpasteurized milk
Avoid drinking untreated water
Always wash hands after touching a pet or barnyard animal
Do not allow toddlers and young children to play with pets or barnyard animals (such as baby chicks or ducklings) unsupervised.

For more information on Campylobacter and other food-borne pathogens, visit the CDC website or read Food Safety: Old Habits, New Perspectives.

Recalls and Alerts: January 28, 2012

Here is today’s list of food safety recalls, product withdrawals, allergy alerts and miscellaneous compliance issues. The live links will take you directly to the official recall notices and company news releases that contain detailed information for each recall and alert.

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United States

Allergy Alert: J&B Group, Inc. (St. Michael, MN) recalls Ellison Meat Company Beef Sirloin Top Butt Steak, Cap Off, No Roll, Marinated (10.5-lb case/28 x 6 oz; Case Code 62149; Est #15805; Produced between Jan 1, 2011 and September 7, 2011) and Ellison Meat Company Beef Sirloin Top Butt Steak Cap Off / Tenderized with Ficin & Bromelain (1-lb cases/16 x 10 oz; Case code 62151; Est #15805; Produced between Jan 1, 2011 and September 7, 2011), due misbranding and to the presence of undeclared milk. The recalled beef sirloin products were supplied for institutional use in Montana, North Dakota and Texas.
Allergy Alert: Giant Eagle recalls Prepared Foods Small Mashed Potato Side Dish, Large Mashed Potato Side Dish, and Mashed Potatoes GNG (all batches), because the prepared foods may contain undeclared soy.
Food Safety Recall: 18th Street Deli Inc. (Hamtramck, MI) recalls 18th Street Deli Julienne Salad, 18th Street Deli Julienne Salad Lite and Balanced Choice Julienne Salad Lite (Est #P-22061; Expiration dates 01/20/12 and 01/30/12), after it was notified by a supplier that their hard-cooked eggs had tested positive for Listeria monocytogenes, and were being recalled by Michael Foods Egg Products Co. The recalled salad products were produced on Jan. 20, 2012 and distributed to retail stores in Michigan and to vending companies in Indiana, Michigan and Ohio.
Food Safety Recall: Michael Foods Inc. (Minnetonka, MN) recalls Papetti’s Brand Hard-Cooked Eggs (25-lb tubs; Lot codes 1362W, 1363W, and 1364W; Use by dates of February 11th, 12th, and 13th, 2012), due to possible contamination with Listeria monocytogenes. The recalled products were distributed to the food service sector during the second week of January, 2012.
Outbreak Alert: The Maryland Department of Health and Mental Hygiene reports six confirmed cases of Campylobacter infections – 3 in Maryland and 3 in Pennsylvania – associated with the consumption of raw milk from the Family Cow Dairy store in Chambersburg, PA. The Family Cow dairy sells directly to consumers at its on-farm retail store and at multiple drop-off locations and retail stores in Bucks, Cumberland, Dauphin, Delaware, Franklin, Lebanon, Montgomery, Philadephia and York counties in Pennsylvania.
Outbreak Alert: The Nebraska Department of Health & Human Services and the New Hampshire Department of Health and Human Services advise the public that there has been a rise in the number of reported norovirus outbreaks since the beginning of the winter season.

Canada

Allergy Alert: The Canadian Food Inspection Agency warns anyone with allergies to egg not to consume Bin Bin brand Snow Rice Crackers (150g pkgs; UPC 8 852098 700124; all lot/date codes), due to the presence of undeclared egg. The product has been distributed in British Columbia, Alberta, Manitoba, and possibly nationally. CFIA is working with importers to removed the product from the marketplace.
Allergy Alert: Winners Merchants International LP recalls Jelly Belly Christmas Deluxe Mix (9-oz/255g pkgs; Best before DEC 01 2012; Product of USA), due to the presence of undeclared milk and wheat. The recall product was distributed across Canada.
Allergy Alert: Pinnacle Foods Group LLC recalls certain Aunt Jemima® Frozen Pancakes (Recommended Use by Date between November 1, 2011 through October 16, 2012), due to the presence of undeclared soy. The following affected products were distributed nationally: Aunt Jemima Buttermilk Pancakes/Crêpes au babeurre (12/420g; UPC 6 9147955822 4), Aunt Jemima Homestyle Pancakes/Crêpes maison (12/420g; UPC 6 9147955912 2) and Aunt Jemima Whole Grain Pancakes/Crêpes grains entiers (12/410g; UPC 6 9147956040 1).

Europe

Food Safety Recall (Belgium): Colruyt and OKay recall certain Topaz Ground Nutmeg products (100g, Lots PO18723 and PO17458; 500g, Lots PO18783 and PO17268) after finding levels of aflatoxin B1 that are slightly in excess of permitted levels.

Some supermarket chains post recall notices on their web sites for the convenience of customers. To see whether a recalled food was carried by your favorite supermarket, follow the live link to the supermarket’s recall web site.