27-29 February 2024
During an inspection of a manufacturer of solid oral dosage forms the FDA observed incidences of water leakage from the ceiling of the encapsulation room: Capsules were exposed to leaks during multiple batch encapsulation operations.
In addition, there were instances of water leaks in the packaging area. Some occurred during filling tablets into open containers. Some of these leaks occurred above the packaging lines. According to the FDA this may pose a risk to the quality of finished drug products, in particular the moisture sensitive drugs. According to the FDA the executive management of the company failed to fully recognize the risks from these leaks.
The FDA therefore requires:
In addition, the FDA commented in the Warning Letter that the manufacturer lacked data showing that the process was in "state of control" before batch release.
On the FDA website you can find the complete Warning Letter to Aurolife Pharma.