Warning Letter to Indian API Manufacturer due to Restricted Access

The US FDA inspected an Indian API manufacturer from 20 March to 3 April 2024 and found serious violations of GMP. The deficiencies relate in particular to quality control, collaboration with a contract manufacturer and violations of regulatory requirements for registration and documentation. As a direct consequence, the FDA issued an import alert.

Inadequate supervision of a contract manufacturer

The manufacturer employed a Contract Manufacturing Organisation (CMO) for the production and packaging of APIs, but did not fulfil its responsibilities as a registered manufacturer. Although stipulated in writing, the Indian API manufacturer had not taken any measures to supervise the contract manufacturer and ensure GMP compliance. For example, no proper process validation had been carried out by the contract manufacturer and the master batch record was incomplete. In addition, analytical methods for testing the APIs were not properly verified. The FDA points out that companies remain entirely responsible for compliance with GMP requirements even when using contract manufacturers.

Access restriction during inspection

Restricting access, both to the facility and to requested documents, is a very serious violation. During the inspection on 15 March 2024, the FDA was initially denied access to the production facility. Later, on 20 March 2024, access was granted, but essential documents such as logbooks, change control forms and analytical test data were not made available.

Violations of registration and listing requirements

According to FDA regulations, all companies that distribute or export drugs in the USA must register their production facilities and list all products. However, one API was not properly registered with the FDA. In addition, the Indian company claimed to be the manufacturer, although production was carried out by an unregistered contract manufacturer.

As a result of the violations, the FDA has issued an import alert. The FDA is calling for a comprehensive review and improvement of the quality system and recommends engaging an independent GMP consultant.

The complete Warning Letter can be found on the FDA website.