GPC Medical Lands Warning Over Process Validation, Labeling Problems
The FDA warned an Indian devicemaker for noncompliances relating to process validation, device acceptance and labeling.
The agency inspected a GPC Medical facility in New Delhi in June of 2017 and found that the firm failed to ensure process corrections would be performed because it did not provide a plan for such corrections or any documentation supporting the corrections. The company also did not properly document finished device sampling procedures.
While the completed product testing plan indicated 100 percent inspection for dimensional acceptance, the product testing report deviated from this plan without any documented justification. In its response to the agency’s inspection observations, the firm said it would make corrections but failed to include any plan or documentation.