SPECIFIC OBSERVATIONS POINT TO THE EVENTUAL LINCOLN, NE RECALL
Novartis Consumer Health, Inc. (NCH) received a Form FDA 483 containing 10 Observations representing 23 pages on January 20, 2012. Several of the Observations were similar to those received in July 2011. Observation 1 is the most inclusive and reads as follows:
“OBSERVATION 1
QUALITY SYSTEM:
Your Quality Unit has failed in the responsibility and authority to monitor Quality systems designed to assure the quality of drug products manufactured and packaged at your firm.
This failure is evidenced in the Observations described below: (Failure to adequately investigate consumer complaints, Failure to assure your processes remain in a current validated state, Failure to conduct complete Annual Product Reviews, Failure to train employees within your operations and quality systems, Failure to extend investigations of known problems to all lots potentially affected, Failure to file adequate NDA Field Alerts in a timely manner and Failure to have an adequate number of trained personnel in your Quality Unit).
This is also evidenced by continued incorrect/incomplete/untimely NDA Field Alerts and numerous product recalls for similar problems over the last several years.
Products affected by this lack of overall Quality oversight include, but are not limited to:
Excedrin (Entire Product Family)
Bufferin (All strengths)
NoDoz, Gas X, Prevacid, Percocet, Morphine Sulfate ER”
This is a repeat Observation from the last FDA inspection at this site, dated 6/13-7/8/11.”
Both of these Form FDA 483s and the Establishment Inspection Report for the July 2011 audit may be found within the ORA Electronic Reading Room.
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