News

The U.S. Food and Drug Administration (FDA) has issued a new Warning Letter following an inspection that uncovered serious GMP deficiencies in the manufacturing of an OTC drug product, including missing release testing, lack of stability data, and inadequate quality oversight.

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.

The US FDA inspected a Chinese API manufacturer from 2 to 6 September 2024 and found significant GMP violations. The deficiencies relate to quality control, cleaning procedures and stability testing. As an immediate consequence, the FDA issued an Import Alert.

A recent FDA Warning Letter to a Chinese OTC manufacturer highlights serious deficiencies in analytical testing, inadequate quality oversight, and multiple data integrity issues. These include missing data, discrepancies between original and re-written testing records and certificates of analysis (COAs), and the use of correction fluid (white-out) to alter laboratory documentation.