Inadequate process control, lack of master production and control records, and inadequate details on training intended to prevent future GMP violations have combined to earn Sunrise Pharmaceutical an FDA warning letter. The letter is part of a protracted correspondence between the drugmaker and the regulator following a month-long inspection last summer.
The current warning follows a mid-November corrective-action response from the company. That response was preceded by two others--in September and July--from the company after the inspection.
One issue involved products formulated with an excess amount of active pharmaceutical ingredient. Although the company had explained that the excess API was required because of "process loss," the regulator required more detail: "You failed to provide documented scientific justification to explain why the excess API is necessary." In addition, none of the losses was documented.
"Your process is not considered to be in an adequate state of control when excess API (than as required in your batch records) is routinely used by your firm. To ensure proper formulation, you must document and justify the need for any excess amount of a component in each batch record," the warning says.
In addition, inspectors found that Sunrise had failed to established laboratory control mechanisms and had failed to document quality control unit review and approval at the time of performance. The FDA notes in the current warning that the company had promised to retrain employees in its July response. "However," the letter says, "we are concerned that this same commitment was made in the past for other deficiencies." The regulator then asks for specifics on the type of training, and how it will prevent recurrence of violations.
- here's the warning letter