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.

Update: Belgian Infant Formula Blamed for Sick Russian Babies

UPDATE #1:

AFSCA, the Belgian food safety authority, announced today (January 23rd) that powdered milk imported from Belgium was believed responsible for infecting infants in the north of Russia with Salmonella Oranienburg. AFSCA reports that just one production lot comprising 19 tonnes was implicated; 16 tonnes were shipped to Russia, and the remaining 3 tonnes – mixed together with other production lots – were supplied to several third-world countries. None of the contaminated milk powder was sold in Belgium, or in any other European country.

AFSCA has inspected the manufacturing facility and is confident that all necessary measures have been taken to prevent a reoccurrence of the contamination.

ORIGINAL ARTICLE (posted January 22, 2012)

Implicated dry milk formula also shipped to Haiti and to several African countries.

Powdered infant formula manufactured by a Belgian company is responsible for 16 cases of salmonellosis in Usolie (Omsk, Irkutsk, Russia), according to a report carried on ProMED mail. The illnesses occurred between November 2, 2011 and January 13, 2012.

Thirteen of the outbreak victims were children aged 2 weeks to 7 months; one was a 4-year old child, and two victims were adults aged 24 and 29 years. All sixteen confirmed victims were infected with Salmonella Oranienburg.

The implicated milk was identified as “Damil a” dry milk formula. It was manufactured in Belgium by FASSKA S.A., and distributed in the Russian Federation by JSC “STI Damil” (Moscow). The implicated batch of dry milk formula carried a date of manufacture of 01.2011.

The Russian distributor has recalled the dry milk formula, which was supplied to wholesale suppliers, large retail chains, pharmacies and health care institutions. In addition, Baku Today reports that the Investigative Committee of the Russian Federation for the Irkutsk region has instituted proceedings under Article 2h 238 of the Criminal Code, on the grounds that the “production, storage, transport or marketing of goods and products do not meet the requirements of security.”

Belgium has notified the Rapid Alert System for Food and Feed (“RASFF” – Notification #2012.0094, issued 17/01/2012 and updated 20/01/2012) that dry milk infant formula linked to an outbreak of Salmonella Oranienburg was supplied to Burundi, The Democratic Republic of the Congo, Congo-Brazzaville, Haiti, Mozambique and the Russian Federation. I have been unable to find any reports of Salmonella Oranienburg illnesses from countries other than Russia.

As usual, the official public notification through RASFF did not identify the manufacturer or brand of the product for which the foodborne outbreak alert was issued. But the coincidence is compelling.

Fasska distributes its products worldwide, and boasts that attention to quality is a “constant obsession that guides each action made and decision taken…” within the company. A statement explaining what steps the company was taking to get to the bottom of the contamination and prevent a reoccurrence would be appropriate – as would a statement from the Belgian government that it was undertaking an investigation of the manufacturing facility.

Russian consumers who have purchased the dry milk powder infant formula have been instructed to return it to the place of purchase and to inform the Omsk region Rospotrebnadzor (regulatory authority).