News

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.

With the draft chapter <1110>, the USP completes its programme with recommendations on the subject of contamination control strategy, as already called for in other documents.

The US FDA recently published a further Warning Letter to a Chinese manufacturer, which has joined the growing list of companies that have established no or inadequate quality control units due to the lack of testing and control of raw materials used.