An FDA inspectional observation report hints at the depth of quality system problems plaguing Novartis Consumer Health Inc.’s Lincoln, Neb., facility, a site the company is downsizing through layoffs and outsourcing to third-party manufacturers.

Seven of the nine observations on the form 483, posted online by FDA April 29, are repeats from inspections in 2011 and 2012, including the failure of quality control personnel to follow applicable procedures for adequately investigating consumer complaints, conducting annual product reviews and extending investigations of known problems to all potentially affected product lots.

In one instance, during the agency’s 18-day inspection of the Lincoln plant in January and February 2013, investigators randomly reviewed nine of 1,066 consumer complaint investigations closed since Oct. 15, 2012. Novartis failed to extend all nine investigations to other potentially affected products.

“This is indicative of a pattern of problem[s] at your firm,” the report says.

Novartis AG CEO Joseph Jimenez on April 24, during the firm’s first-quarter earnings call, sought to assure analysts that the form 483 raised no issues with NCH’s manufacturing process, and that FDA’s observations focused on consumer complaint handling Also see "Novartis Divests Non-Core OTCs, Realigns Consumer Supply Chain" - Pink Sheet, 29 April, 2013..

Brian McNamara, division head of Novartis OTC, said during the call that Lincoln had a backlog of consumer complaints at the time it was shuttered for remediation in late 2011, and has continued receiving and handling complaints as they are submitted. He added that the firm is “aggressively working to remediate” the complaint handling process with the help of consultants.

Jimenez said the backlog of complaints is cleared up, though the remediation apparently had not gone far enough when FDA came knocking.

“We believe that we’ve got the right things in place to get it done, but it just wasn’t enough,” he said. “It was a tough audit, obviously, and it was written up [with] areas that need to improve in the coming months.”

Quality Processes Still Lacking

Novartis corrected manufacturing issues at Lincoln cited in a January 2012 form 483, including concerns that equipment was not cleaned and maintained at appropriate intervals to prevent product contamination Also see "FDA Pressure Likely In Novartis OTC Plant Shutdown, Recalls" - Pink Sheet, 6 February, 2012.. After receiving a significant number of consumer complaints regarding chipped and stray tablets around that time, Novartis opted to recall products including Excedrin, Gas-X and the since-divested Bufferin brand.

The manufacturing deficiencies have been remediated, but NCH management at Lincoln seems to have progressed little in overhauling other processes in the 12 months following the facility shutdown.

For example, FDA officials discovered that the firm closed its investigation into a report of a 1-year-old child opening and drinking half a bottle of Triaminic Cough & Cold syrup after a week without extending the investigation to other liquid OTCs with potential child-resistant closure failures.

Further, the agency found 429, or 40%, of Lincoln’s 1,066 complaint investigations were not concluded within the 30 days prescribed by the facility’s written procedures. And in the case of the Triaminic-drinking toddler, NCH’s written complaint investigation report omitted pertinent facts surrounding the product review, such as the recommendation of a recall assessment, FDA says.

The agency’s investigators identified a potential culprit for the undetected container closure problems: QC lab technicians’ failure to store Triaminic and other liquid products in an inverted or horizontal position in the stability chamber, which may have allowed problems to go undetected.

“Due to the storage of all samples in a vertical position, Novartis was unable to detect any problems with the container closure system,” which had the potential to lead to deterioration or contamination of the enclosed product, the FDA report states.

Novartis is now cutting its losses at the 150,000-square-foot Lincoln facility, once NCH’s largest. Though it has returned to producing the Sentinel animal health product, Lincoln will be streamlined from producing five drug delivery formats to just two – solids and powders, mainly for Sentinel, Excedrin and Theraflu.

Third-party manufacturers now have responsibility for Excedrin Extra Strength and Migraine, Lamisil and Triaminic. Novartis expects Benefiber to return to market by the end of June and Theraflu is slated for later in 2013, according to an April 24 filing with the Securities and Exchange Commission.

The Swiss firm’s supply chain realignment is companywide, as it is in the process of exiting, restructuring or divesting 18 production sites. Novartis said in the SEC filing that its program “to optimize our manufacturing footprint” has cost $466 million – including charges for production transfers and inventory write-offs – since it began in fourth quarter 2010.

Novartis OTC Plant Troubled By Quality Failures A Year After Shutdown

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