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Sun Pharmaceutical Industries Ltd received six observations to its Halol plant for inspections done from 27 August to 31 August by the U.S. FDA to the drug maker.
The Halol unit in June received an ‘establishment inspection report’ from the US FDA post an inspection conducted between 12 February and 23 February of this year, paving the way for its first drug approval of the Infugem injection used for treating cancer during the last 5 years.
The facility was recently cleared by the U.S. regulator manufactures most of the niche future filings from India’s largest drugmaker, including injectables. Some of the observations received by the company are:
Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to assure that drug product conform to appropriate standards of identity, strength quality and purity.
The procedure designed to prevent microorganisms in drug products not required to be sterile are not followed. The written stability programme for drug products does not include sample size based on statistical criteria for each attribute examined to assure valid estimates of stability.
There are no written procedures for production and process controls designed to assure that the drug products have the identity, strength, quality and purity they purport or are represented to possess.
