The French National Agency for Medicines and Health Products Safety issued a warning letter to Indian API maker Dhanuka Labs after inspectors found a risk for product contamination and other issues at its Gurgaon, Haryana, plant.
In its letter posted on the EudraGMPD website, the French regulatory agency said an inspection conducted in late March found a total of 24 deficiencies at the factory that produces APIs for antibiotics, including cephalosporin.
Of the issues, one was critical in that inspectors found multiple risks of contamination. Other problems listed as major included water-quality control, insufficient maintenance of the plant, material storage issues and validation problems.
In its letter, the agency recommended a recall be issued of batches already released. Additionally, it called for the plant to be prohibited from supplying APIs until the issues at the facility are resolved.
The plant was cited for similar problems in 2016 following an inspection conducted by Croatia’s Halmed agency, which found critical issues with the plant's quality-assurance protocols, documentation and materials management.