Warning Letter: Deficiencies in Visual Inspection

Recommendation

4/5 December 2019
Berlin, Germany

Continuous Manufacturing - Development, Production and Quality

In October 2014, the US FDA issued a Warning Letter to the company Hikma Pharmaceuticals because of deficiencies in the visual inspection of vials and environmental monitoring.

Already in a Warning Letter issued in 2011, a deficiency in the visual inspection was noted as the detection and evaluation of particulate matter failed to be sufficient. Now, the current complaint in the area of visual control explicitly refers to the qualification of staff for the performance of the manual visual inspection. Here, the FDA inspectors noticed that visible markings were present on the qualifcation test sets which enabled operators for visual inspection to recognize - thanks to these markings - vials with particles. The qualification of staff has been thus completely questioned and therefore also the qualification of the whole visible inspection. According to the FDA, an assessment of the batches reviewed and released to the market by non-qualified personnel was missing in the written reply to this complaint.

Source: Warning Letter issued to the company Hikma Pharmaceuticals.