Eugia Pharma Specialities Limited — FDA 483 Findings

There is a failure to thoroughly review any unexplained discrepancy and the failure of a batch or any of its components to meet any of its specifications whether or not the batch has been already distributed.

Aseptic processing areas are deficient regarding systems for maintaining any equipment used to control the aseptic conditions.

Procedures designed to prevent microbiological contamination of drug products purporting to be sterile did not include adequate validation of the aseptic process.

Testing and release of drug product for distribution do not include appropriate laboratory determination of satisfactory conformance to t he final specifications prior to release.

The responsibilities and procedures applicable to the quality control unit are not fully followed.

Aseptic processing areas are deficient regard ing the system for monitoring environmental conditions.

Employees are not given training in the particular operations they perform as part of their function.

Laboratory records do not include the initials or signature of a second person showing that the original records have been reviewed for accuracy.

Test procedures relative to appropriate laboratory testing for pyrogens are not followed.

Established laboratory control mechanisms are not followed.

Procedures designed to prevent microbiological contamination of drug products purporting to be sterile are not established, written and followed.