Eugia Pharma Specialities Limited — FDA 483 Findings

The responsibilities and procedures applicable to the Quality Unit are not fully followed.

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

Establishment of the reliability of the component supplier's report of analyses is deficient in that the test results are not appropriately validated at appropriate intervals.

Laboratory controls do not include the establishment of scientifically sound and appropriate test procedures designed to assure that drug products conform to appropriate standards of identity, strength, quality and purity.

Control procedures are not established which monitor the output and validate the performance of those manufacturing processes that may be responsible for causing variability in the characteristics of in-process material and the drug product.

Equipment used in the manufacture, processing, packing or holding of drug products is not of appropriate design to facilitate operations for its intended use.

Aseptic processing areas deficient regarding system for monitoring environmental conditions.

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

Equipment and utensils are not cleaned, sanitized at appropriate intervals to prevent contamination that would alter the safety, identity, strength, quality or purity of the drug product.