> ## Content Index
> Fetch the complete content index at: https://www.fdaweb.com/llms.txt
> Use this file to discover other available public pages before exploring further.

# Laurus Labs Cited on GMPs in India
- URL: https://www.fdaweb.com/laurus-labs-cited-on-gmps-in-india/
- Published: 2024-05-23T12:00:00.000Z
- Updated: 2026-09-14T14:31:44.000Z
- Author: David McFarland
- Tags: Drugs, #legacy-id-D5157045

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](https://www.fda.gov/media/178841/download?attachment&ref=fdaweb.com) 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.