Sun Pharmaceutical Issued Warning Letter for Microbial Violations

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PTSM: Pharmaceutical Technology Sourcing and Management

PTSM: Pharmaceutical Technology Sourcing and Management-01-06-2016, Volume 12, Issue 1

Inadequate response to violations cited in a 2014 inspection leads to an FDA warning letter for Sun Pharmaceutical Industries.

The Sun Pharmaceutical Industries facility in Halol, Gujarat, India was cited by FDA in a Dec. 17, 2015 warning letter for violations ranging from failure to prevent microbial contamination in aseptic drug products, ceiling leaks in manufacturing areas, failure investigate out-of-specification issues in batches, and other violations identified during a Sept. 8–19, 2014 inspection.

FDA noted that Sun Pharmaceutical’s response of Oct. 10, 2014 lacked sufficient corrective action and acknowledged additional correspondence from the company in 2014 and 2015.

FDA reported that the company failed to perform adequate unidirectional airflow studies under dynamic conditions to determine how the movement of air and personnel during aseptic operations could pose risks to product sterility. Although the company committed to new smoke studies in its initial response to FDA’s Form 483, FDA reports that the company has not has submitted neither a revised smoke test or a satisfactory new smoke study.

FDA also noted that the company rejected vials during media fills without written adequate explanation, and should provide a risk assessment regarding the practice of rejecting media fill vials without a written justification and acceptance limits.


The inspection revealed that the floors, walls, and ceilings in the aseptic processing area were not maintained as smooth, hard surfaces that were easily cleaned; in addition, there were water stains and ceiling damage in the parenteral manufacturing area personnel corridor caused by leaks; buckets with water collected from ceiling leaks and other leaks in this manufacturing area were observed by the FDA inspector. FDA noted that the company failed to address environmental control in the parenteral manufacturing area to determine how the leaks could compromise the product.

FDA also cited the company for not thoroughly investigating unknown impurities or their root causes in certain drug batches; did not evaluate the accuracy of its dissolution test method for tablets; used an un-validated and unqualified data acquisition unit to monitor the temperature of the microbiological incubation rooms for media filled vials; and failed to establish appropriate controls over computers and related systems to assure that only authorized personnel can change master production and control records or other records.

Source: FDA