FDA Recap of Warning Letters, Import Alerts and Non-Compliances 2017

Data integrity continued to be a hot topic in the pharmaceutical industry through 2017. According to a recent analysis by GMP (good manufacturing practices) intelligence expert, Barbara Unger, approximately 65 percent of all US Food and Drug Administration (USFDA) warning letters issued in FY2017 (October 1, 2016 until September 30, 2017) included a data integrity component.


However, in the previous year, this number was even higher — at 79 percent — implying there has been a decline in non-compliance incidents pertaining to data integrity in 2017.


2017’s recurring concern – a failure to thoroughly investigate problems

In PharmaCompass’ 2016 compilation, serious charges of blatant data manipulation surfaced at organizations around the world. 


In 2017, we witnessed a reduction in data-integrity violations uncovered at pharmaceutical manufacturers due to the absence of audit trail software in quality control testing equipment.


However, the implementation of audit trails has resulted in the emergence of a new failing – the improper handling of out-of-specification (OOS) results.


Failure “to thoroughly investigate any unexplained discrepancy or failure of a batch” became a recurring theme in concerns highlighted at major generic players like Mylan, Fresenius, Teva, Dr Reddy’s, Hetero Labs and Lupin.


In the case of Fresenius’ oncology API plant in India, USFDA investigators found employees had halted and invalidated HPLC (high-performance liquid chromatography) analyses nearly 250 times when they believed the tests were going to end with OOS results. 


The USFDA warned Fresenius SE after the company’s Indian plant that makes cancer-drug ingredients for the US market aborted hundreds of drug-quality tests.


The situation at Lupin wasn’t much better as the warning letter issued to its formulation manufacturing facilities in Goa and Indore (Pithampur Unit II) said the company failed to “thoroughly review any unexplained discrepancy” as Lupin invalidated approximately 96 percent of all OOS results obtained at Pithampur and over 75 percent of them in Goa. 


Failure to resolve recurring problems also led the USFDA to tell Meridian Medical Technologies, a division of Pfizer that makes the EpiPen injector device (sold by Mylan NV), that serious component and product failures had been associated with patient deaths.


In its warning letter, the USFDA said the Pfizer unit failed to adequately investigate problems at its manufacturing facility in Brentwood, Missouri. It also did not take appropriate corrective actions before a USFDA inspection earlier this year.


Meridian had received hundreds of complaints that the EpiPen device, which is used to combat serious allergic reactions, failed to operate during life-threatening emergencies.


Click here for our compilation of all non-compliances in 2017 (Excel version available) for FREE!


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