French inspectors found a lot they didn’t like about an Indian manufacturer when they inspected its operation for consideration of approving its ambroxol hydrochloride API. The problems led the European Medicines Agency to raise questions about the plant’s production of other active ingredients.
The recent inspection of the Kores facility in Roha, India, found five major deficiencies. They included problems with data integrity, validation of computers and several issues with risks of contamination or cross-contamination.
The report pointed out that Italian authorities had found the plant out of compliance during an inspection in 2017 and suspended its certificate to produce certain APIs.
The EMA noted that the plant manufactured more than 15 APIs for treatments that include heart disease, asthma and diabetes. The deficiencies pose the likelihood that those products also could be compromised, the French inspectors pointed out.
The EMA noted data integrity issues with another Indian API maker recently. An inspection of a Mercury Laboratories plant in Jarod, India, found 20 deficiencies, including one critical and six major deficiencies. The critical deficiency was tied to authenticity of manufacturing records. Inspectors said production records and quality risk assessment records could not be verified.