Strides Pharma, a Bangalore, India-based pharmaceutical company, has received a Warning Letter from the US Food and Drug Administration (FDA) for violations of current good manufacturing practice (cGMP) regulations for finished pharmaceuticals following an inspection of the company’s drug-manufacturing facility in Puducherry, India. The FDA conducted the inspection from January 28 to February 5, 2019. 

In its Warning Letter, the FDA said that the company’s quality unit lacks appropriate responsibility and control over its drug-manufacturing operations. During the inspection, the FDA said that it observed discarded cGMP documents and evidence of uncontrolled shredding of documents. The FDA said that uncontrolled destruction of cGMP records and the lack of adequate documentation practices raises questions about the effectiveness of the company’s quality unit and the integrity and accuracy of its cGMP records.

The agency also cited the company for closing investigations of out-of-specification (OOS) results without adequate scientific justification. The agency also cited the company for data-integrity issues for not adequately ensuring the accuracy and integrity of data to support the safety, effectiveness, and quality of the drugs the company manufactures.

With respect to the OOS results, the FDA is requiring the company to provide a thorough review of production (e.g., batch manufacturing records, adequacy of the manufacturing steps, raw materials, process capability, deviation history, batch failure history) for any OOS results with inconclusive or no root cause identified in the laboratory. It is also requiring the company to provide a corrective action and preventive action (CAPA) plan that identifies root causes and specifies meaningful improvements. Additionally, it is requiring the company to provide all reserve sample testing results, all analytical data for the API and drug product batches, including any batches manufactured using API with associated OOS results with inconclusive or no root cause.

With respect to the data-integrity issues, the FDA is requiring the company to make an assessment of the extent of data-integrity deficiencies at its facility, identify omissions, alterations, deletions, record destruction, non-contemporaneous record completion, and other deficiencies, and describe all parts of the facility’s operations in which it discovered data-integrity lapses. It also is requiring the company to make a current risk assessment of the potential effects of the observed failures on the quality of its drugs and to provide a management strategy that includes the details of the company’s CAPA plan. That CAPA plan is to include how the company intends to ensure the reliability and completeness of all data generated by the company, including microbiological and analytical data, manufacturing records, and all data submitted to the FDA.

Source: US Food and Drug Administration