Exchange of information between National Competent Authorities (NCAs) of the EEA following the discovery of serious GMP non-compliance at a manufacturer (1)洒下大网，不好玩。

Nature of non-compliance : 1. Contamination of Absorbable Collagen Sponges with particulate matter is not under control. ACS sheets are exposed to an ISO Class 7 environment without protection by Grade A air. This is relevant during the loading and unloading of the cross-linking chamber, the cutting of the sponges, the visual inspections and the (re)packaging stage. Embedded particles do occur but are not always removed during visual inspection if seen. During visual inspection tweezers are used constantly to remove visible contaminants from the surface of sponges. This is regarded by the company as a part of routine production. A comprehensive analysis of the root cause of contamination is not conducted. Packaging material seems to be a source of foreign matter, but other than vacuuming trays before packaging (which proved to be insufficient) no preventive measures have been taken. Static charges contribute to the problem of particulate matter contamination, as was seen by a hair that was stuck on the outside of a container used to store sponges for a long time. The design and functioning of the sponge cutting table as a source of particulate contaminants has not been considered. 2. The quality system is not aiming for continuous improvement; manufacturing processes are not designed in a way that product quality is achieved consistently: extensive corrective inspections are performed, repackaging of a significant number of units is routinely necessary due to quality defects, and rejection of significant parts of the batches is accepted as normal. An investigation initiated to improve the process is defective: contaminants removed during the visual inspection of unpackaged sponges are left out of the investigation, which is limited anyway to 2 batches only without proper justification.Prohibition of supply Applies to batches of InductOs released after 16 April 2015

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