Warning Letter due to non-transparent Supply Chain of APIs

Recommendation

28-30 March 2023

Global Registration and Life Cycle Management of APIs - Live Online Training
Contents of the regulatory information in the ASMF and CEP

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:

• Employees drive their cars to the different production sites where Sal Pharma acquires the APIs and transport them to a clearing agent.
• There, APIs are repacked, relabelled and stored. The personnel indicated to the inspectors that it cannot be ensured that the APIs are stored in a temperature-controlled environment at the clearing agent. 
• During the repacking / relabelling steps, the entire original manufacturer's information was removed from the labels and the COA, and replaced by "Sal Pharma".

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.