26-28 October 2021
The company CTX Life Sciences Pvt., Ltd - a manufacturer of APIs based in the state of Gujarat in India received the visit of FDA inspectors in February 2016. The outcome of this inspection was the issuance of a Warning Letter on 18 January 2017. This letter presents a range of serious deficiencies. Those deficiencies violate fundamental requirements and show that there is hardly any awareness of GMP-compliant manufacturing and controlling at this site. The Warning Letter lists the following deficiencies:
During their tour, the inspectors observed rust, insects, damaged interiors and product residues on the manufacturing equipment which had the "clean" status. As this equipment was in use and partly in direct contact with products, the inspectors saw a considerable risk of contamination.
Diverse product batches had been released without performing the required UV spectrometry test. The reason for that was that the UV spectrophotometer was defective. In its response, the company states that according to the quality department the batch release was justified since all other release tests had been passed. For the FDA, this argument was definitely unacceptable.
The inspectors discovered a customer complaint who had measured in a product batch a higher water content deviating from the specification. This measurement was also higher than the value calculated by the quality control. The reason for that was due to the fact that the QC was not using a validated testing method.
In the Warning Letter, the FDA requires statements on the deficiencies criticised coupled with the provision of extensive information on improvement measures and data on the already delivered batches. All theses actions are expected to avoid the threatening import ban in the USA on APIs manufactured by this company.
Please also see the FDA's Warning Letter to CTX Lifescience Private Ltd.