In late December, India-based Sun Pharma received a warning letter citing sterility concerns at its manufacturing site in Halol, India. In the letter, inspectors reported there were buckets in the parenteral manufacturing space collecting water from overhead leaks. FDA concerns included the way that media fill records failed to include a specific description for why Sun rejected vials from certain batches.
Also, the company failed to perform adequate airflow studies to determine how the movement of air and personnel during aseptic operations could pose sterility risks.
To learn more, read the FDA warning letter
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