Laurus Labs Cited on GMPs in India

FDA has cited Laurus Labs (Hyderabad, India) over GMP deficiencies following a 12/2023 inspection at the firm’s active pharmaceutical ingredient (API) manufacturing facility in Andhra Pradesh, India.

During the inspection, the agency says in a just-posted untitled letter that it determined that the firm’s quality unit failed to ensure that critical deviations were investigated and resolved. For example, it says that during a hold time study for an undisclosed ingredient, a timepoint result was out of specification for assay and an unspecified impurity.

The inspection also found that Laurus failed to clean equipment and utensils to prevent contamination or carry-over of a material that would alter the quality of the API beyond the official or other established specifications.

Additionally, the FDA letter recommends that the firm retain a GMP consultant to evaluate its operations and to assist it in meeting GMP requirements.