29/30 September 2021
The Indian company Sal Pharma has recently received a Warning Letter due to serious deficiencies regarding the procurement, transport and distribution of APIs. The inspectors described the company's procedures as follows:
As the inspectors uncovered this practice, they found that in the past APIs from two unknown i.e. not registered manufacturers had been delivered to the USA. Because of the information stated in the certificate of analysis and on the label, it seemed that the exported APIs came directly from Sal Pharma - which is an obvious case of fraud.
Sal Pharma's response given right after the inspection according to which exports to the USA would be first suspended to take into consideration the inspectors' complaints was insufficient for the FDA and led to the present Warning Letter. Indeed, Sal Pharma made no statement with concrete details about corrective measures regarding its non-compliant GMP procedures.
One interesting detail should be noticed: more and more, the FDA explicitly points out in its Warning Letters that API manufacturers should base their assessment of GMP-compliance on ICH Q7 ("FDA considers the expectations outlined in ICH Q7 in determining whether API are manufactured in conformance with CGMP").
More details can be found in the Warning Letter issued to Sal Pharma.