FDA 483 - Sentiss Pharma Pvt. Ltd. - May 23, 2017

Sentiss Pharma Pvt. Ltd., located in Himachal Pradesh, India, underwent an FDA inspection from May 15 to May 23, 2017. The inspection identified ten major areas of concern regarding the facility"s sterile manufacturing processes and quality management systems. Primary violations included significant data integrity failures, where the firm neglected to investigate the extent of previous record inaccuracies or establish a root cause for data lapses. Aseptic processing was also found to be deficient; media fill validations—which simulate production to ensure sterility—did not reflect actual run times, and smoke studies revealed air turbulence in critical areas. The company also failed to qualify suppliers for essential materials, including the growth media used for sterility testing, and lacked scientific justification for its cleanroom incubation temperatures. Other issues involved poor cleaning procedures, inadequate laboratory controls for impurity testing, and a lack of documented practical training for microbiology staff. These findings were issued as an FDA Form 483, which serves as a report of preliminary observations that may indicate a violation of federal quality standards. Sentiss Pharma is required to respond to these observations by submitting a detailed corrective action plan or providing objections to the findings. The FDA will then evaluate these responses to determine if further regulatory action or a formal warning is necessary to ensure the safety and purity of the drug products manufactured at the site.