eFoodAlert

“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.