Hetero Receives FDA Warning LetterBy
The US Food and Drug Administration (FDA) has issued a Warning Letter for current good manufacturing practice (cGMP) violations for finished pharmaceuticals to Hetero Labs, a Hyderabad, India-headquartered pharmaceutical company, for its drug-manufacturing facility in Telangana, India.
Among the deficiencies noted by the FDA, the agency cited the company for having insufficient investigations into process deviations and out-of-specification laboratory results and not providing scientifically supported conclusions, including for failed dissolution testing.
In response, the FDA said that the company must provide: (1) a detailed retrospective review of all complaint, manufacturing, and laboratory investigations associated with each product that it produces for the US market, and all lots that are within expiry; (2) a detailed retrospective review of the manufacturing process validation for each product that can be exported to the US; and (3) a plan to ensure that all future investigations are thorough, scientifically sound, and result in appropriate and effective corrective and preventive action (CAPA).
The firm was also cited for a product in poor condition that contained colored residue. In response, the FDA said that the company must provide: (1) the sampling procedures and analytical methods it used to test the residues, including validation protocols and validation reports; (2) a detailed retrospective review of the manufacturing process validation for each product that can be exported to the US; and (3) an overall assessment of the adequacy of its cleaning program for all equipment, with special emphasis on difficult-to-clean parts.
The firm was also cited for its quality-control unit’s failure to follow the company’s written procedures regarding the recall of failing products. In response, the company must provide a list and summary explanation for all other instances in which product(s) distributed within the last five years failed to meet established specifications, but for which it failed to take actions prescribed by its quality system manual and recall procedure. Also, it must provide its planned CAPA for each such instance and explain its CAPA for ensuring that it follows its own procedures regarding product quality and recalls.
Lastly, the FDA cited the firm for not having an adequate ongoing program for monitoring process control to ensure stable manufacturing operations and consistent drug quality.