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MARKET INTEL by PharmaCompass
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By PharmaCompass
2019-02-14
Impressions: 134 Article
In November 2017, Lupin had received a warning letter for its formulation manufacturing facilities in Goa and Indore (Pithampur Unit II). The observations of the inspections specifically highlighted Lupin’s continued “failure to thoroughly review any unexplained discrepancy” as Lupin invalidated approximately 96 percent of all out-of-specification (OOS) results obtained at Pithampur and over 75 percent of them in Goa.
Last week, following a recent FDA inspection at its Indore (Pithampur Unit II) facility, the FDA posted the Form 483 issued to the facility, which has once again highlighted concerns over Lupin’s handling of OOS results.
In the case of Moxifloxacin Ophthalmic Solution, not only were Lupin’s investigation practices questioned, but the firm failed to conduct a detailed health-hazard assessment until the time of the inspection, six months after the original OOS result was obtained.
The Form 483 also mentions that Lupin’s Corrective and Preventive Actions (CAPA) were not scientifically sound.
In addition to Lupin’s deficient investigative practices, there were also concerns about the ability of its laboratory personnel to properly conduct the required analytical test. Moreover, there were concerns over Lupin’s maintenance of electronic data as access to the system was not adequately controlled.
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