The US Food and Drug Administration (FDA) inspection took place from May 5 to May 15, 2019, at Lupin’s Maharashtra state, India, facility.
In total, the Form 483 noted three observations regarding production issues at the finished drug site, with the most notable issue being a failure to file written records of inspections regarding faults discovered internally.
The heavily redacted first observation stated that from the period July 2017 until February 2019, the testing of tablets produced at the site led the company to discover products were out of specification.
However, the FDA observed that no corrective actions were taken at the time, as well as employees concluding “manual errors” were part of the cause not filing documentation regarding what type of manual error.
In one instance, a complaint regarding a human hair being embedded within a tablet did not result in an expanded investigation “to determine microbial contamination or impact.”
The report goes on to note that “Laboratory controls do not include the establishment of scientifically sound and appropriate specifications, standards sampling plans and test procedures designed to assure that components, in-process materials and drug products confirm to appropriate standards of identity, strength, quality and purity.”
Lupin’s Aurangabad site is home to a formulations plant and an R&D centre, as well as producing anti-tuberculosis medicine.
In a statement, the company noted that it is “confident of addressing [the observations] satisfactorily.”
The company has faced previous regulatory action from FDA regarding product recalls and inspections, towards the end of last year and the beginning of 2019.
Launches product on US market
On the same day that the FDA made its Form 483 public, Lupin confirmed that it had launched its budesonide inhalation suspension, 0.5 mg/2 mL single-dose ampules onto the US market.
The medication is a generic version of AstraZeneca’s Pulmicort product, which the company lost patent protection on in 2015.
The product is a maintenance treatment for asthma in children from 12 months to eight years of age.
