Alchymars Warned for Falsified Data, Maintenance Issues
The FDA hit Indian API manufacturer Alchymars ICM SM with a warning letter after an investigation found the firm falsified laboratory data, failed to thoroughly investigate complaints and improperly maintained equipment and facilities at its Chennai, Tamil Nadu facility.
In a September inspection, the FDA discovered the firm was falsifying laboratory data. The number of colony-forming units the investigator found on plates used for water point-of-use tests differed significantly from the number recorded on the firm’s water report.
In addition, the firm reported no traces of growth on a selective media plate used to detect contaminants which the investigator found to be untrue, a serious health concern as it could affect water used to manufacture products intended to be used in sterile injectable dosages.
Improperly maintained equipment was also observed during the inspection. A manhole gasket was wrapped in peeling tape and deteriorating, while another gasket was also wrapped in tape and cracked. The firm’s standard operating procedure requires it to replace broken gaskets but the facility had no gasket replacement records.