News

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.

The U.S. Food and Drug Administration (FDA) has issued a new Warning Letter due to CGMP violations related to combination products. Key violations include inadequate controls to ensure the sterility of drug products, deficient dissolution testing, and a lack of process validation.